FDA UDI
In Commercial Distribution
🇺🇸 United States
Sample Diluent Tube
DI: 18053326004527
·
Model: 0C018S
·
COPAN ITALIA SPA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- Sample Diluent Tube
- Primary DI
- 18053326004527
- Version / Model
- 0C018S
- Catalog Number
- 0C018S
- Company Name
- COPAN ITALIA SPA
- Labeler DUNS
- 428981112
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2024-05-07
- Public Version
- 1
- Public Version Date
- 2024-05-15
- Public Version Status
- New
- Public Device Record Key
- 3231b280-ae2d-433d-b0ce-4cc022958ba0
Device Description
1ML SAMPLE DILUENT TUBE IN BULK
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PPM | General Purpose Reagent | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58237 | Buffered sample diluent IVD | A buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 28053326004524 | GS1 | 6 | In Commercial Distribution | ||
| Primary | 18053326004527 | GS1 | ||||
| Unit of Use | 08053326004520 | GS1 |