Identity
- Trade Name
- PIVO 20G FDA UDI
- Generic Name
- Blood collection tube holder, single-use FDA UDI
- Device Name
- PIVO (2.0) 20G compatible device. FDA UDI
- Model / Reference
- 202-0005 FDA UDI
- Description
- PIVO (2.0) 20G compatible device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850984007027 FDA UDI
- 510(k) Number
- K163508 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Blood collection tube holder, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood collection tube holder, single-use
Pivo 20g by Velano Vascular, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K163508 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Velano Vascular, Inc.
Sources (1)
- FDA UDI 5b3e5380-ad45-4494-8586-b7daef6fc152 35 fields · synced May 29, 2026