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BALLOON DILATION CATHE

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SPE2DS-27-T-1064Federal

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Solicitation SPE2DS-27-T-1064 is issued by the Department of Defense, specifically the DLA Troop Support Medical Supply Chain, for the procurement of five Equalizer Occlusion Balloon Dilation Catheters for cardiovascular use. The required device must feature an inflated diameter of 20mm, a usable length of 100cm, a recommended inflation volume of 4.8ml, a 14F introducer size, and a 7F catheter size. Technical specifications include a dual-lumen design, a minimum tip ID of 0.039 inches, and a recommended guidewire of 0.038 inches. The items are subject to a non-extendable 12-month shelf life and must be delivered FOB Destination to San Antonio, Texas, within five days after receipt of order. This procurement is strictly regulated by the FDA under Regulation 870.4450 Class II, requiring a 510(k) and compliance with registration, listing, and labeling standards. Packaging must adhere to MIL-STD-2073-1E and DLA RP001, while marking must follow Medical Marking Standard No. 1. The contract incorporates various FAR and DFARS clauses, including the Buy American Act, safeguarding of covered defense information, and HUBZone price evaluation preferences. Bidders must submit quotes via DIBBS and provide a complete data package for any alternate parts offered. Invoicing and receiving reports are to be processed electronically through the Wide Area WorkFlow system.

General Info

DoD solicitation for five cardiovascular Equalizer Occlusion Balloon Dilation Catheters.

NAICS

339112 - Surgical and Medical Instrument Manufacturing

Place of Performance

601 DAVY CROCKETT RD, SAN ANTONIO, TX, 78226, USA

Set-Aside

NONE

Documents

1

RFQ SPE2DS-27-T-1064

PDF, High priority: read this firstrfq
High

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Timeline

PhaseSolicitation
Posted

Solicitation

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Organization & Contact Information

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AgencyDepartment Of Defense → MEDICAL SUPPLY CHAIN MD SURG FSF
Contacts1 person available
OfficeUSA

Full Description

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BALLOON DILATION CATHETER,CARDIOVASCULAR
BALLOON CATHETER<(>,<)> VASCULAR-NONVASCULAR; EQUALIZER OCCLUSION BALLON
CATHETER. UNIT OF ISSUE IS EACH. INFLATED DIAMETER 20MM; USABLE LENGTH
100CM; RECOMMENDED BALLOON VOLUME INFLATION 4.8ML; INTRODUCER SIZE 14F
(4.0MM). CATHETER SIZE 7F (2.3 MM); NUMBER OF LUMEN 2; MINIMUM TIP ID
0.039 inches (0.99 MM); RECOMMENDED GUIDEWIRE 0.038 inches (0.97 MM).
RA001: THIS DOCUMENT INCORPORATES TECHNICAL AND/OR QUALITY REQUIREMENTS (IDENTIFIED BY AN 'R' OR AN 'I' NUMBER) SET FORTH IN FULL TEXT IN THE DLA MASTER LIST OF TECHNICAL AND QUALITY REQUIREMENTS FOUND ON THE WEB AT:
http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx
FOR SIMPLIFIED ACQUISITIONS, THE REVISION OF THE MASTER IN EFFECT ON THE SOLICITATION ISSUE DATE OR THE AWARD DATE CONTROLS. FOR LARGE ACQUISITIONS, THE REVISION OF THE MASTER IN EFFECT ON THE RFP ISSUE DATE APPLIES UNLESS A SOLICITATION AMENDMENT INCORPORATES A FOLLOW-ON REVISION, IN WHICH CASE THE AMENDMENT DATE CONTROLS.
RP001: DLA PACKAGING REQUIREMENTS FOR PROCUREMENT
RQ011: REMOVAL OF GOVERNMENT IDENTIFICATION FROM NON-ACCEPTED SUPPLIES
RD003, COVERED DEFENSE INFORMATION POTENTIALLY APPLIES
This device or drug is regulated by the FDA. Note to Buyers: The contracting official shall send a referral in EBS to the product specialist for confirmation. Please include bidder name and bidder contact information, manufacturer name, manufacturer part number, and item description. RS011: Shelf-life requirement RS001 for a TYPE I (CODE H) item with a shelf life of 12 months (non-extendable) applies to this item.
BIDDER: PLEASE SPECIFY SOURCE AND PART
NUMBER BEING SUPPLIED.
ADEQUATE DATA FOR THE NSN/Part Number: 6515-01-701-4546 Quantity: 5 EA Purchase Request: 7018136235QTY: 5 Delivery: 5 days ADO

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