AccessGUDID - DEVICE: i-STAT hs-TnI cartridge (10054749003058)

GUDID

Device Identifier (DI) Information

Brand Name: i-STAT hs-TnI cartridge
Version or Model: 09P81-25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 09P81-25
Company Name: Abbott Point of Care Inc.

Primary DI Number: 10054749003058
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116279183 *Terms of Use

Device Description: i-STAT hs-TnI 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):	No
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?
54009	Troponin I IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of troponin I in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMI	IMMUNOASSAY METHOD, TROPONIN SUBUNIT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240984	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: 70c2f289-4e05-47ca-9deb-3a68848bda07
Public Version Date: May 07, 2025
Public Version Number: 1
DI Record Publish Date: April 29, 2025