FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Blood Specimen Convenience Kit
DI: 10859952006076
·
Model: SA95204
·
CAPITOL VIAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Blood Specimen Convenience Kit
- Primary DI
- 10859952006076
- Version / Model
- SA95204
- Company Name
- CAPITOL VIAL, INC.
- Labeler DUNS
- 151639481
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-31
- Public Version
- 3
- Public Version Date
- 2023-08-23
- Public Version Status
- Update
- Public Device Record Key
- 07d1774c-6204-4d7f-a038-1601db516055
- Distribution End Date
- 2021-12-31
Device Description
Convenience Kit
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| JKA | Tubes, vials, systems, serum separators, blood collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63061 | Capillary blood collection system IVD | An assembly of devices intended to be used for the collection, preservation, and/or transportation of capillary blood for subsequent analysis and/or other investigation. It is a self-contained unit consisting of micro-needles and a container with a pre-measured amount of vacuum. The device is intended to be placed against the skin where the needles make shallow perforations, from which blood is drawn from the capillaries into the container via the vacuum. It may or may not contain a preservative or anticoagulant (e.g., lithium heparin). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30859952006070 | GS1 | Case | 48 | Not in Commercial Distribution | 2021-12-31 |
| Primary | 10859952006076 | GS1 |