ChemWell2

GUDID 00850229007461

AWARENESS TECHNOLOGY, INCORPORATED

Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory
Primary Device ID00850229007461
NIH Device Record Keyd3abb4b3-c0a5-4ebc-bd05-8ed7b7434692
Commercial Distribution StatusIn Commercial Distribution
Brand NameChemWell2
Version Model Number5100
Company DUNS071065130
Company NameAWARENESS TECHNOLOGY, INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850229007461 [Primary]

FDA Product Code

JJQColorimeter, Photometer, Spectrophotometer For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-13
Device Publish Date2023-06-05

Devices Manufactured by AWARENESS TECHNOLOGY, INCORPORATED

00850229007010 - StatFax2023-06-13
00850229007027 - StatFax2023-06-13
00850229007034 - StatFax2023-06-13
00850229007041 - StatFax2023-06-13
00850229007072 - StatFax2023-06-13 Digital Dry Bath
00850229007089 - StatFax 2023-06-13 Digital Dry Bath
00850229007102 - StatFax2023-06-13
00850229007126 - LumiStat2023-06-13

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