FDA UDI
In Commercial Distribution
🇺🇸 United States
Camco
DI: 00691573200005
·
Model: 2000
·
CAMBRIDGE DIAGNOSTIC PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Camco
- Primary DI
- 00691573200005
- Version / Model
- 2000
- Catalog Number
- 2000
- 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
- 8fa9e9f9-8c44-4209-ab19-60f76ac03005
Device Description
Camco Poly-Tet stain - Wright stain with blue-red coloration with high intensity color projection and electrolytes for sharper contrast.
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 | 00691573200005 | GS1 |
Customer Contacts
- Phone
- 954-971-4040
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1 | Quart |
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. Keep containers tightly closed