FDA UDI
In Commercial Distribution
🇺🇸 United States
PIVO Pro Needle-free Blood Collection Device
DI: 00382903936519
·
Model: 393651
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- PIVO Pro Needle-free Blood Collection Device
- Primary DI
- 00382903936519
- Version / Model
- 393651
- Catalog Number
- 393651
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 124987988
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-09
- Public Version
- 2
- Public Version Date
- 2025-07-04
- Public Version Status
- Update
- Public Device Record Key
- 8ad392a2-5fe7-4f82-bd7b-f41e93e7cca1
Device Description
PIVO Pro Needle-free Blood Collection Device 24GA
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
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 44903 | Blood transfer set | A collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30382903936510 | GS1 | Pack or Inner Pack | 50 | In Commercial Distribution | |
| Primary | 00382903936519 | GS1 | ||||
| Package | 50382903936514 | GS1 | Case | 4 | In Commercial Distribution |