ChemWell

GUDID 00850229007232

AWARENESS TECHNOLOGY, INCORPORATED

Multiple clinical chemistry analyser IVD, laboratory
Primary Device ID00850229007232
NIH Device Record Key8306f2b8-e992-4e5c-b97f-22f9ff07c6f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameChemWell
Version Model Number2910
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
GS100850229007232 [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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