Identity
- Trade Name
- 20G Open-System Ally Blood Collection Device FDA UDI
- Generic Name
- Blood collection set, noninvasive FDA UDI
- Model / Reference
- AV100000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850042365007 FDA UDI
- 510(k) Number
- K220258 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Blood collection set, noninvasive 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
Dimensions & Sizes
- Size
- Outer Diameter — 0.0274 Inch FDA UDI
Category: Blood collection set, noninvasive
20G Open-System Ally Blood Collection Device by Avia Vascular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K220258 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
- Avia Vascular
Sources (1)
- FDA UDI 80eb8b2f-f89a-446b-b111-a8d1f8e3e584 34 fields · synced Jun 6, 2026