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

• Primary Device ID: 10054749005717
• NIH Device Record Key: cc1c3eb2-0f82-4545-818a-30b67093586f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-STAT G Cartridge
• Version Model Number: 03P83-26
• Catalog Number: 03P83-26
• Company DUNS: 079226216
• Company Name: ABBOTT POINT OF CARE INC.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00054749005710 [Primary]
GS1	10054749005717 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223755

FDA Product Code

• CGA: GLUCOSE OXIDASE, GLUCOSE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-08
• Device Publish Date: 2024-04-30

Devices Manufactured by ABBOTT POINT OF CARE INC.

• 00054749004911 - i-STAT hs-TnI Calibration Verification, Levels 1-3: 2025-05-12 i-STAT hs-TnI Calibration Verification, Levels 1-3
• 00054749004928 - i-STAT hs-TnI Control Level 1: 2025-05-12 i-STAT hs-TnI Control Level 1
• 00054749004935 - i-STAT hs-TnI Control Level 2: 2025-05-12 i-STAT hs-TnI Control Level 2
• 00054749004942 - i-STAT hs-TnI Control Level 3: 2025-05-12 i-STAT hs-TnI Control Level 3
• 00054749003051 - i-STAT hs-TnI cartridge: 2025-05-07 i-STAT hs-TnI cartridge
• 00054749005772 - i-STAT TBI cartridge: 2024-07-16 i-STAT TBI cartridge
• 10054749005717 - i-STAT G Cartridge: 2024-05-08i-STAT G Cartridge
• 10054749005717 - i-STAT G Cartridge: 2024-05-08 i-STAT G Cartridge
• 10054749005670 - i-STAT G3+ Cartridge: 2023-12-26 For the whole blood quantitative determination of pH pCO2 PO2 HCO3 TCO2 BE sO2