AccessGUDID - DEVICE: Bartels® (05391516745864)

GUDID

Device Identifier (DI) Information

Brand Name: Bartels®
Version or Model: B1029-44C
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: B1029-44C
Company Name: TRINITY BIOTECH PUBLIC LIMITED COMPANY

Primary DI Number: 05391516745864
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 988298840 *Terms of Use

Device Description: Bartels® HSV Type 1 and Type 2 Antigen Control Slides

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?
52840	Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GQL	Antisera, Fluorescent, Herpesvirus Hominis 1,2

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
Device Size Text, specify: 5 Sets

Device Record Status

Public Device Record Key: 11d4faec-afe0-42ec-94cd-538877c1b2c7
Public Version Date: May 10, 2019
Public Version Number: 4
DI Record Publish Date: September 23, 2016