AccessGUDID - DEVICE: i-STAT PTplus Control Level 2 (00054749004850)

GUDID

Device Identifier (DI) Information

Brand Name: i-STAT PTplus Control Level 2
Version or Model: 06P17-18
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 06P17-18
Company Name: Abbott Point of Care Inc.

Primary DI Number: 00054749004850
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 116279183 *Terms of Use

Device Description: For use with i-STAT PTplus cartridges

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):	Yes

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
55985	Prothrombin time (PT) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GJS	TEST, TIME, PROTHROMBIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220282	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 539828e4-0eeb-4a25-83c4-4bdf29d2f1fa
Public Version Date: January 18, 2024
Public Version Number: 1
DI Record Publish Date: January 10, 2024