Camco

Basic Information

• Brand Name: Camco
• Primary DI: 00691573400009
• Version / Model: 400
• Catalog Number: 400
• Company Name: CAMBRIDGE DIAGNOSTIC PRODUCTS INC
• Labeler DUNS: 069146876
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-10
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 62c32ccd-6b89-44b5-bace-c7f5a0ccff68

Device Description

Camco Wright Stain solution for automated and manual staining of blood smears for hematological studies.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KQC	Stains, Hematology	Hematology	864.1850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00691573400009	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	1	Gallon

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: 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. Store tightly closed & upright