AccessGUDID - DEVICE: i-STAT TBI cartridge (00054749005772)

GUDID

Device Identifier (DI) Information

Brand Name: i-STAT TBI cartridge
Version or Model: 03S09-25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03S09-25
Company Name: Abbott Point of Care Inc.

Primary DI Number: 00054749005772
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116279183 *Terms of Use

Device Description: i-STAT TBI cartridge

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
66468	Multiple traumatic brain injury marker IVD, kit, rapid non-ICT electrochemical immunoassay, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple biochemical markers associated with traumatic brain injury in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid electrochemical immunoassay method [excludes immunochromatographic tests (ICT)]. This test is commonly used in the laboratory or in point-of-care analyses to detect glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) as an aid to determine the need for a neuroimaging scan following head injury. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QAT	Brain trauma assessment test

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K234143	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 67b4fc66-b3c7-4d91-ba82-eaf6967cb54c
Public Version Date: July 16, 2024
Public Version Number: 1
DI Record Publish Date: July 08, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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