i-STAT G Cartridge 03P83-26

GUDID 10054749005717

i-STAT G Cartridge

ABBOTT POINT OF CARE INC.

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Primary Device ID10054749005717
NIH Device Record Keycc1c3eb2-0f82-4545-818a-30b67093586f
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-STAT G Cartridge
Version Model Number03P83-26
Catalog Number03P83-26
Company DUNS079226216
Company NameABBOTT POINT OF CARE INC.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100054749005710 [Primary]
GS110054749005717 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGAGLUCOSE OXIDASE, GLUCOSE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-08
Device Publish Date2024-04-30

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