AccessGUDID - DEVICE: GEM Test APTT Cartridges (08426950088561)

GUDID

Device Identifier (DI) Information

Brand Name: GEM Test APTT Cartridges
Version or Model: 06260034000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 06260034000
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950088561
Issuing Agency: GS1
Commercial Distribution End Date: January 25, 2024
Device Count: 45
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: GEM Test APTT 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:	No
Prescription Use (Rx):	Yes
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?
55983	Prothrombin time (PT) IVD, kit, clotting	A collection of reagents and other associated materials 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), using a clotting method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JPA	SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

FDA Premarket Submission

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

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: 01751ec3-181c-4a30-9cfb-c1669ce4e5cd
Public Version Date: January 26, 2024
Public Version Number: 6
DI Record Publish Date: September 23, 2016