AccessGUDID - DEVICE: Trinity Biotech (05391516744546)

GUDID

Device Identifier (DI) Information

Brand Name: Trinity Biotech
Version or Model: Enzyme Cleaner Tube
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-12-0001
Company Name: PRIMUS CORPORATION

Primary DI Number: 05391516744546
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790074793 *Terms of Use

Device Description: Hemoglobin A1c assay, Enzyme Cleaner Tube

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):	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?
38773	Medical device-decontamination agent	A non-sterile substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental, surgical instruments/devices, and/or laboratory analysers/instruments for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds (decontamination) prior to disinfection or sterilization. It includes a detergent and may be added, as manufacturer specified, to water for cleaning procedures and/or be applied directly to soiled devices immediately after use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LCP	Assay, Glycosylated Hemoglobin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K891235	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 28 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8167b124-42c3-4b4d-8696-19383a24bccc
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 06, 2016