RESUSCITATOR, HAND OPER
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The contract specifies the procurement of 2 packages of 12 hand-operated adult resuscitators each, totaling 24 units, with the NSN 6515-01-531-4715 and manufacturer part number 520-211-000 from AMBU INC. Each package must be sealed in a unit container that protects the device from damage, and all shipping containers must ensure safe, cost-effective delivery to Fort Carson, Colorado, with FOB destination terms. The resuscitators are classified as a Class II medical device regulated by the FDA, requiring compliance with 510(k) premarket notification, registration, labeling, and GMP standards. All packaging and labeling must conform to Medical Marking Standard No. 1, superseding MIL-STD-129, and each unit must be marked with the manufacturer’s name, CAGE code, date of manufacture prefixed by “MFD”, expiration or retest date, contract number, and lot number. Delivery is required within 20 days with zero tolerance for quantity variance, and inspection and acceptance occur at the destination. The procurement is governed by DLA packaging and technical requirements, and the contract falls under simplified acquisition procedures with the solicitation issued under SPE2DS-26-T-276V and response due by August 3, 2026.
General Info
Agency
NAICS
Place of Performance
BLDG 7465 BAD TOELZ RD, FORT CARSON, CO, 80913-4093, USSet-Aside
Documents
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Full Description
RESUSCITATIOR, HAND PUMP; DISPOSABLE; ADULT; 12S
.
Size 5 . UNIT OF ISSUE IS A PACKAGE OF 12 EACH . LABELS SHALL INCLUDE: NSN MANUFACTURER AND CAGE DATE OF MANUFACTURE, EXPIRATION, OR RETEST DATE CONTRACT NUMBER/LOT NUMBER . MARKINGS ON ALL CONTAINERS SHALL INCLUDE THE LOT (CONTROL) NUMBER AND DATE OF MANUFACTURE PREFIXED BY "MFD".
APPLICABLE TO ALL MEDICAL ACQUISITIONS:
PACKAGING AND PACKING SHALL BE COMMERCIAL AS SPECIFIED IN THE PROCUREMENT DOCUMENT.
EACH COMPLETE UNIT SHALL BE PROPERLY PACKAGED IN A SUITABLE SEALED UNIT CONTAINER CAPABLE OF PROTECTING THE CONTENTS FROM DAMAGE AND/OR BREAKAGE.
UNITS SHALL BE PACKED IN SUITABLE COMMERCIAL EXTERIOR (SHIPPING) CONTAINERS (EXPORT WHEN NECESSARY) WHICH SHALL INSURE ACCEPTANCE AND SAFE DELIVERY BY COMMON OR OTHER CARRIER, AT THE LOWEST RATE, TO POINT OF DELIVERY CALLED FOR IN THE CONTRACT OR ORDER.
MATERIAL MUST BE MARKED IAW MEDICAL MARKING STANDARD NO. 1. THIS SUPERCEDES ALL REFERENCES TO MIL-STD-129.
COPIES OF MEDICAL MARKING STANDARD NO. 1 (MMS NO. 1) MAY BE OBTAINED BY CONTACTING DLA TROOP SUPPORT VIA EMAIL TO fssb@dla.mil. MMS NO. 1 IS ALSO AVAILABLE ONLINE AT: https://www.dla.mil/Logistics-Operations/Packaging/
RD003, COVERED DEFENSE INFORMATION POTENTIALLY APPLIES
RP001: DLA PACKAGING REQUIREMENTS FOR PROCUREMENT
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.
SPE2DS-26-T-276V
SECTION B
RQ011: REMOVAL OF GOVERNMENT IDENTIFICATION FROM NON-ACCEPTED SUPPLIES
INCLUDES OXYGEN TUBING, RESERVOIR, BAG, MASK;
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. REGULATION 868.5915 CLASS II EVEN THOUGH A 510(K) IS REQUIRED, IT IS NECESSARY TO MEET OTHER REQUIREMENTS FOR MARKETING. THESE INCLUDE: REGISTRATION AND LISTING, LABELING OR GMP'S
1 PG = 12 EA
AMBU INC. 65891 P/N 520-211-000
TDP Rev A Gen 1 IAW REFERENCE REVISION NR DTD PART PIECE NUMBER:
DLA issues this document using the DoD authorized unit of issue, please refer to the following URL to determine the corresponding ANSI X12 unit of issue.
https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.dla.mil%2FPortals%2F104%2FDocuments% 2FDLMS%2FeApplications%2FLogDataAdmin%2FUnitofIssueandPurchaseUnit.xlsx&wdOrigin=BROWSELINK
CLIN PR PRLI UI QUANTITY UNIT PRICE TOTAL PRICE.
0001 7017631892 0001 PG 2.000
NSN/MATERIAL:6515015314715
DELIVERY (IN DAYS):0020
DELIVER FOB: DESTINATION
QTY VARIANCE: PLUS 0% MINUS 0%
INSPECTION POINT: DESTINATION
ACCEPTANCE POINT: DESTINATION
PREP FOR DELIVERY:
PKGING DATA MIL-STD-2073-1E
SPECIAL NSN/Part Number: 6515-01-531-4715 Quantity: 2 PG Purchase Request: 7017631892QTY: 2 Delivery: 20 days ADO
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