Ultrasonic unit, diagnostic, human
Closed Pre-Solicitation Posted
This opportunity was awarded. See the award notice from , or the latest solicitation from .
- Solicitation number
- SPE2DH24Q0022
- Agency
- Medical Supply Chain Troop Support, Department of Defense
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 339113 Surgical Appliance and Supplies Manufacturing
- Place of performance
- Tripler Army Medical Center, Hawaii 96859, United States
Notice details come from SAM.gov. Updated .
About this opportunity
This pre-solicitation notice seeks to procure a human diagnostic ultrasonic unit including a Lumify L12-4 Linear Array Transducer and Lumify S4-1 Sector/Phased Array Transducer along with a tablet/app bundle from the Defense Logistics Agency Troop Support Medical. The bundle must include a charging cable, custom tablet case, Lumify cables, paper user manual, instructions on CD, and carry bag. Offerors must meet FDA requirements for registration, listing, labeling and GMPs. The deadline for questions is October 20, 2023.
There is no set-aside designated for this procurement. The goods fall under NAICS code 334510 and PSC code 6525. The potential incumbent is Philips North America LLC for product number NUSH023. Compliance with FDA regulation 892.2050 is required though a 510(k) is not. The contracting officer is to verify bidder information with the product specialist.
Notice text
ULTRASONIC UNIT,DIAGNOSTIC,HUMAN
LUMIFY L12-4 LINEAR ARRAY TRANSDUCER; AND LUMIFY S4-1 SECTOR/PHASED ARRAY TRANSDUCER; TABLET/APP WITH RUGGED SLEEVE BUNDLE. RUGGED BUNDLE INCLUDE CHARGING CABLE,CUSTOM TABLET CASE (RUGGED), LUMIFY USB-C CABLE, LUMIFY MICRO USB CABLE, PAPER USER MANUAL, INSTRUCTIONS FOR USE ON A CD, AND CUSTOM CARRY BAG.
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 892.2050 CLASS II EVEN THOUGH A 510(K) IS NOT REQUIRED, IT IS NECESSARY TO MEET OTHER REQUIREMENTS FOR MARKETING. THESE INCLUDE: REGISTRATION AND LISTING, LABELING OR GMP'S.
NSN 6525-01-691-2239 , 07.28.2022
UNIT OF ISSUE: EACH (EA)
PHILIPS NORTH AMERICA LLC 0ZBJ4 P/N NUSH023
Notice history
| Notice | Type | Posted |
|---|---|---|
| Ultrasonic unit, DIA | Award Notice | |
| Ultrasonic unit, DIA | Solicitation | |
| Ultrasonic unit, diagnostic, human | Pre-Solicitation |
On GovTribe
Work this opportunity on GovTribe
- Track it in your pipeline
- Find teaming partners
- Similar opportunities
- Ask GovTribe AI about this opportunity