DANLEE MEDICAL KIT
- Primary DI
- 00816310020009
- Brand
- DANLEE MEDICAL KIT
- Company
- DANLEE MEDICAL PRODUCTS, INC
- Model
- CAR470007501
- Device description
- MICROSAFE TUBE KIT (ZKIT) CONMED
- Published
- 2016-05-17
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00816310020009 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00816310020009 | 00816310020009 | 816310020009 | 0816310020009 |
GMDN Terms
| Term | Definition |
|---|
| Capillary blood collection tube, no additive | A non-sterile glass or plastic collection tube containing no additive, intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin). It is typically sealed at one or both ends with a putty-like substance following specimen collection, This is a single-use device. |
Regulatory Flags
- DUNS number
- 878130871
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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