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ResQPod Circulatory Enhancer Manufacturing and Supply

Active
Federal

Contract Overview

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This subcontract involves the manufacture and supply of 10 finished ResQPod Circulatory Enhancer units, identified by NSN 6515-01-696-7098, for prime contractors supporting Defense Logistics Agency supply contracts. The production must take place in FDA-approved Class II Medical Device facilities, ensuring strict adherence to Good Manufacturing Practices and Medical Marking Standard No. 1. The manufacturer is required to comply with FDA Regulation 868.5250, which includes maintaining all necessary 510(k) marketing requirements, registrations, and listings. This procurement falls under NAICS code 339113 and is managed through the Department of Defense.

General Info

Manufacture and supply 10 ResQPod units following FDA and DoD medical device standards.

NAICS

339113 - Surgical Appliance and Supplies Manufacturing

Place of Performance

Not specified

Set-Aside

NONE

Documents

This scope was carved out of SPE2DS-27-T-1331.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

ENHANCER, CIRCULATOR

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Timeline

Posted

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Organization & Contact Information

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AgencyDepartment Of Defense → Defense Logistics Agency
ContactsNo contacts available
OfficeN/A
Office AddressN/A
ContactsNo contact information available

Full Description

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Supplies finished ResQPod Circulatory Enhancer units for prime contractors delivering DLA supply contracts. Manufactures 10 units per FDA Regulation 868.5250, maintaining 510(k) marketing requirements, registration, and listing. Adheres to Good Manufacturing Practices (GMP) and applies medical marking per Medical Marking Standard No. 1. Requires FDA-approved Class II Medical Device production facilities. Delivers 10 units of NSN 6515-01-696-7098.

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