AccessGUDID - DEVICE: i-STAT (10054749000125)

GUDID

Device Identifier (DI) Information

Brand Name: i-STAT
Version or Model: 03P84-25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03P84-25
Company Name: ABBOTT POINT OF CARE INC.

Primary DI Number: 10054749000125
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079226216 *Terms of Use

Device Description: CREATININE 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?
30205	Creatinine/ammonium electrode IVD	An electrochemical sensor in which an interaction between one or more immobilized enzymes (e.g., creatinine iminohydrolase) and creatinine occurs, developing an electrical potential or current proportional to the quantity of ammonium (NH4+) resulting from the reaction. The electrode may use one of several technologies (e.g., enzyme immobilized by adsorption) and mechanisms (e.g., diffusion of ammonium). It is used to measure creatinine in body fluids (e.g., urine).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGL	ELECTRODE, ION BASED, ENZYMATIC, CREATININE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K973292	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
Handling Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 62fff855-b4aa-4371-b1cf-9f5e95fa7bc0
Public Version Date: May 23, 2024
Public Version Number: 5
DI Record Publish Date: September 09, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00054749000128	25	10054749000125		In Commercial Distribution	Case

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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