AccessGUDID - DEVICE: Camco (00691573702066)

GUDID

Device Identifier (DI) Information

Brand Name: Camco
Version or Model: 702-B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 702-B
Company Name: CAMBRIDGE DIAGNOSTIC PRODUCTS INC

Primary DI Number: 00691573702066
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 069146876 *Terms of Use

Device Description: Camco Stain Pak Solution I -Part of a three step staining system approximating results obtained from either Wright or Wright-Giemsa Stain.

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?
43587	Biological stain IVD	A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.	Active	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: Store in a tightly closed container. Containers which are opened must be carefully resealed and kept upright to prevent leakage. Do not store in direct sunlight.

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1 Gallon

Device Record Status

Public Device Record Key: 3fcbe511-4b1a-41e1-a979-3312d67832ef
Public Version Date: March 11, 2019
Public Version Number: 3
DI Record Publish Date: March 10, 2017