AccessGUDID - DEVICE: i-STAT (10054749001986)

GUDID

Device Identifier (DI) Information

Brand Name: i-STAT
Version or Model: 06P23-25
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 06P23-25
Company Name: ABBOTT POINT OF CARE INC.

Primary DI Number: 10054749001986
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 079226216 *Terms of Use

Device Description: CARTRIDGE, cTnI

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?
54013	Troponin I IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of troponin I in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMI	IMMUNOASSAY METHOD, TROPONIN SUBUNIT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Handling Environment Temperature: between 2 and 8 Degrees Celsius
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: bfbc6b4e-86df-4d61-b1a7-30e324cf0c4e
Public Version Date: March 25, 2022
Public Version Number: 3
DI Record Publish Date: September 09, 2016