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OUTSET MEDICAL, INC.

UEI: CFJQLLFTKZK5CAGE: 5LLN1

OUTSET MEDICAL, INC. is a federal contractor, registered under UEI CFJQLLFTKZK5 and CAGE code 5LLN1. It has been awarded $32,311,932 in federal contracts. Primary work spans Electromedical and Electrotherapeutic Apparatus Manufacturing and Other NAICS codes (1 codes, <0.5% each). Top awarding agencies include Department Of Health And Human Services and Other agencies (1 agencies, <0.5% each).

Contact Information

Registration and classification details

Registration

UEI Code

CFJQLLFTKZK5

CAGE Code

5LLN1

Entity Structure

Corporate Entity (Not Tax Exempt)

Established

N/A

Business Classifications

For Profit OrganizationManufacturer of Goods

NAICS Codes

334510Electromedical and Electrotherapeutic Apparatus Manufacturing(Primary)

Federal Contracting Overview

Award totals, agency breakdown, NAICS distribution, and geographic footprint.

AI Capability Profile

Outset Medical, Inc. specializes in the design, development, and manufacturing of advanced medical devices, with a focus on innovative dialysis systems engineered for home and clinical use. Leveraging deep expertise in biomedical engineering, fluid dynamics, and embedded medical software, the compan...

Outset Medical, Inc. specializes in the design, development, and manufacturing of advanced medical devices, with a focus on innovative dialysis systems engineered for home and clinical use. Leveraging deep expertise in biomedical engineering, fluid dynamics, and embedded medical software, the company delivers integrated renal care solutions that emphasize patient safety, portability, and clinical efficacy. Their technical capabilities include real-time sensor integration, closed-loop control systems, FDA-regulated software validation, and compliance with ISO 13485 quality management standards. A key differentiator is their proprietary technology platform that enables portable, single-use dialysis systems, reducing infection risk and operational complexity compared to traditional hemodialysis equipment. Award history is not available to determine specific agency relationships or procurement patterns. Consequently, no definitive agency experience can be inferred from the provided data. The company operates primarily within the medical device manufacturing sector, aligned with NAICS 334510, which encompasses the production of electrodiagnostic and therapeutic equipment. In practice, this means Outset Medical focuses on developing Class II and Class III medical devices subject to rigorous FDA premarket review, with vertical specialization in nephrology and chronic kidney disease management. Their market positioning centers on disrupting conventional dialysis care delivery through compact, user-centric technology designed for both institutional and home-based settings. Outset Medical, Inc. is structured as a private, for-profit entity headquartered in San Jose, California. The company does not hold any active government certifications such as 8(a), HUBZone, or WOSB. Its geographic presence is concentrated in California, with operations geared toward commercial and healthcare provider markets rather than direct federal procurement. The firm’s government market positioning remains undefined due to lack of publicly available contract performance data.

Key Performance Metrics

Awards Count

3

All time

Active

0

Currently performing

Completed

3

Past period of performance

Total Awards

All time

Contracts

Prime · all time

Subcontracts

Sub · all time

Grants

Prime · all time

Subgrants

Sub · all time

Award Analytics & Distribution

Awards by Agency
Department Of Health And Human Services$32.3M100%
Other agencies (1 agencies, <0.5% each)$6.6K0%
Awards by NAICS
334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing$32.3M100%
Others - Other NAICS codes (1 codes, <0.5% each)$6.6K0%
Awards by Agency Over Time
Awards by Place of Performance

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Open opportunities in OUTSET MEDICAL, INC.'s top NAICS codes and agencies

NAICS: 334510
New
Federal
Ultrasound Diagnostic System, Hand Carried (USHC) - Prototype
Solicitation # W91CRB-RPP-USHC
The U.S. Army, through the Portfolio Acquisition Executive Maneuver Ground and Project Manager Maneuver Medical Devices, is soliciting prototype proposals for a hand-carried Ultrasound Diagnostic System (USHC). This effort is structured as a Direct Other Transaction Agreement under 10 U.S.C. 4022, meaning it is not a FAR-based contract. The government seeks a Commercial-Off-The-Shelf or Non-Developmental Item capable of supporting medical operations in austere Role of Care 3 environments, specifically for FAST exams, ultrasound-guided procedures, and ruling out deep vein thrombosis. Selected vendors must deliver two prototype units for operational and environmental testing in accordance with MIL-STD-810H. The system must be FDA cleared for human use, Trade Agreements Act compliant, and capable of operating on both CONUS and OCONUS power infrastructures. The estimated period of performance is twelve months, with prototype delivery expected 45 to 60 days after award. Evaluation is based on a comparative best-value methodology, prioritizing technical approach, performance compliance, reliability, schedule realism, and past performance over cost. Key requirements include MIL-STD-130N compliant IUID marking, NIST SP 800-171 cybersecurity compliance, and a minimum one-year warranty. Proposals must be submitted via DoD SAFE or secure email by November 6, 2026, and must adhere to strict page limits across four specific volumes. Notably, participants in this prototype agreement may be eligible for a noncompetitive follow-on production contract.
W6QK Acc-Apg

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about 10 hours ago

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in 16 days
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NAICS: 334510
New
Federal
Automated Ultrasound-Based, Super Intelligence (SI)-Enabled Fracture Detection
Solicitation # BARDA-FY27-10192026
The Center for Biomedical Advanced Research and Development Authority (BARDA) has issued Sources Sought Notice BARDA-FY27-10192026 to identify innovative medical countermeasure technologies for the rapid triage of musculoskeletal injuries, such as fractures and soft tissue injuries of extremities. This request for information is intended for planning and market research purposes to assess commercially available or nearing-commercial technologies that utilize Super Intelligence (SI) and machine learning for automated ultrasound-based fracture detection. The goal is to find standalone, point-of-care devices that can operate in emergency departments, urgent care centers, and austere field settings without relying on traditional imaging infrastructure like X-ray or CT scans. The desired technology must feature automated volumetric capture, 3D-rotatable modeling, and SI-enabled image processing that outperforms human imaging experts and has undergone FDA 510k clearance processes. BARDA is interested in ruggedized, portable units with sufficient battery life for disaster response, interoperability with electronic health record systems, and minimal training requirements for non-specialist operators. Potential acquisition strategies being explored include direct purchases, leases, or vendor-managed inventory arrangements. Interested small businesses and other than small business concerns under NAICS code 334510 must submit their capabilities statements by 1:00 p.m. Eastern Time on November 18, 2026. Submissions must include separate Technical and Business Representation sections, each limited to 10 pages in 12-point Times New Roman font, and be emailed to Justin Moore and Richard Hall. Responses should detail the company's manufacturing capabilities within the United States, regulatory maturity, supply chain resilience, and cybersecurity standards for handling sensitive patient health information.
Barda - Aspr / Daappo / Barda Dcma

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1 day ago

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in 28 days
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NAICS: 334510
New
Federal
Electro-Therapeutic Modalities for Pain Management (ETMPM) - Transcutaneous Electrical Nerve Stimulation (TENS) Procurement Program
Solicitation # 36C79126R0011
The Department of Veterans Affairs is soliciting proposals under Solicitation Number 36C79126R0011 to establish multiple Firm-Fixed-Price, Indefinite Delivery/Indefinite Quantity (IDIQ) base contracts for the Electro-Therapeutic Modalities for Pain Management (ETMPM) and Transcutaneous Electrical Nerve Stimulation (TENS) Procurement Program. This national program provides FDA-cleared electro-therapeutic devices and accessories to support non-opioid pain management across 168 VA Medical Centers and over 1,000 Community Based Outpatient Clinics. The scope includes portable TENS units, portable Interferential Current (IFC) devices, thermal and non-thermal Short-Wave Diathermy devices, and portable Neuromodulation systems for headache disorders, along with associated accessories such as electrodes and lead wires. All products must be OEM-new, feature a one-year warranty, and meet universal Minimum Technical Requirements, including FDA 510(k) clearance for home use. The procurement utilizes a VA Tiered Set-Aside Evaluation Approach, prioritizing Service-Disabled Veteran-Owned Small Businesses (Tier 1), followed by Veteran-Owned Small Businesses (Tier 2), other small business concerns (Tier 3), and finally other-than-small business concerns (Tier 4). Evaluation is based on a per CLIN/SLIN basis; CLINs X001 through X004 are awarded using the Lowest Price Technically Acceptable (LPTA) methodology, while CLIN X005 is evaluated via a Best Value Tradeoff process weighted at 60% Technical, 25% Price, and 15% Past Performance. Responsive proposals must be submitted electronically by October 30, 2026, at 3:00 PM CDT, and must include a signed SF 1449, a Technical Capability Statement, FDA clearance letters, and required certifications including the Buy American or Trade Agreements certificates depending on the offeror's business size. Additionally, product samples must be shipped to the Denver Logistics Service facility in Golden, Colorado, by the same deadline.
Commodities & Services Acquisition Service (36C791)

POSTED

5 days ago

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in 9 days
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