i-STAT TBI cartridge 03S09-25

GUDID 00054749005772

i-STAT TBI cartridge

Abbott Point of Care Inc.

Multiple traumatic brain injury marker IVD, kit, rapid non-ICT electrochemical immunoassay, clinical

• Primary Device ID: 00054749005772
• NIH Device Record Key: 3f2d00cc-5b67-48c7-aa53-07b285f04604
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-STAT TBI cartridge
• Version Model Number: 03S09-25
• Catalog Number: 03S09-25
• Company DUNS: 116279183
• Company Name: Abbott Point of Care Inc.
• Device Count: 1
• 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
• 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
• 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
• 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
• 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	00054749005772 [Package]; Contains: 10054749005779; Package: BX [25 Units]; In Commercial Distribution
GS1	10054749005779 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234143

FDA Product Code

• QAT: Brain trauma assessment test

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: 2024-07-16
• Device Publish Date: 2024-07-08

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: 2024-07-16i-STAT TBI cartridge
• 00054749005772 - i-STAT TBI cartridge: 2024-07-16 i-STAT TBI 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