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
