i-STAT G3+ Cartridge 03P78-26

GUDID 10054749005670

For the whole blood quantitative determination of pH pCO2 PO2 HCO3 TCO2 BE sO2

Abbott Point of Care Inc.

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

• Primary Device ID: 10054749005670
• NIH Device Record Key: b09a94b8-e1af-4b7b-a949-0869adcde4a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-STAT G3+ Cartridge
• Version Model Number: 03P78-26
• Catalog Number: 03P78-26
• Company DUNS: 116279183
• 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: +1-888-366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1-888-366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1-888-366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1-888-366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1-888-366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1-888-366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1-888-366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1-888-366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1-888-366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1-888-366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1-888-366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1-888-366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1-888-366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1-888-366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1-888-366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1-888-366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1-888-366-8020
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00054749005673 [Primary]
GS1	10054749005670 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223857

FDA Product Code

• CHL: Electrode measurement, blood-gases (pco2, po2) and blood ph

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-26
• Device Publish Date: 2023-12-18

Devices Manufactured by Abbott Point of Care Inc.

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• 10054749005717 - i-STAT G Cartridge: 2024-05-08 i-STAT G Cartridge
• 10054749005670 - i-STAT G3+ Cartridge: 2023-12-26For the whole blood quantitative determination of pH pCO2 PO2 HCO3 TCO2 BE sO2
• 10054749005670 - i-STAT G3+ Cartridge: 2023-12-26 For the whole blood quantitative determination of pH pCO2 PO2 HCO3 TCO2 BE sO2
• 10054749004024 - i-STAT: 2023-10-02 Dispensing Tip, 100 Pack
• 10054749000088 - i-STAT: 2023-09-12 6+ CARTRIDGE
• 10054749000071 - i-STAT: 2023-09-11 EC8+ CARTRIDGE
• 10054749000095 - i-STAT: 2023-09-11 EC4+ CARTRIDGE
• 10054749000101 - i-STAT: 2023-09-11 E3+ CARTRIDGE