AccessGUDID - DEVICE: Camco (00691573200005)

GUDID

Device Identifier (DI) Information

Brand Name: Camco
Version or Model: 2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2000
Company Name: CAMBRIDGE DIAGNOSTIC PRODUCTS INC

Primary DI Number: 00691573200005
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 069146876 *Terms of Use

Device Description: Camco Poly-Tet stain - Wright stain with blue-red coloration with high intensity color projection and electrolytes for sharper contrast.

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):	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?
44946	Romanowsky stain IVD, kit	A collection of chemical agents, dyes, and/or other associated materials referred to as a Romanowsky stain, Giemsa, May-Grünwald, Wright, Leishman, Jenner or Field stain, intended to be used for the demonstration of haematopoietic cells, chromosomes, blood parasites, and/or other blood-based pathogens in biological/clinical specimens.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KQC	Stains, Hematology

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
Special Storage Condition, Specify: Keep away from heat, sparks and flame. Keep away from sources of ignition. Store in a cool, dry, well-ventilated area away from incompatible substances. Flammables-area. Keep containers tightly closed

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1 Quart

Device Record Status

Public Device Record Key: 8fa9e9f9-8c44-4209-ab19-60f76ac03005
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: March 10, 2017