AccessGUDID - DEVICE: CARDINAL HEALTH (50885380158948)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: CHB-GS-QC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CHB-GS-QC
Company Name: CARDINAL HEALTH 200, LLC

Primary DI Number: 50885380158948
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 112164780 *Terms of Use

Device Description: Control Slides for use with Single Slide Automate Gram Stainer

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
43650	Gram stain IVD, control	A prepared slide and/or other associated material used to verify the performance of a Gram stain/staining kit (also referred to as Brown and Benn or Brown-Hopps stain) which is intended to be used for the demonstration and differentiation of bacteria in biological/clinical specimens.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LJG	QUALITY CONTROL SLIDES

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9062f9cb-4b74-401d-b0d7-3022a3c54b50
Public Version Date: September 27, 2018
Public Version Number: 2
DI Record Publish Date: August 27, 2018