Identity
- Trade Name
- AV1016-01 Avoset 250mL Medication Reservoir Pouch FDA UDI
- Generic Name
- Electric infusion pump administration set, single-use FDA UDI
- Device Name
- 250mL Medication Reservoir FDA UDI
- Model / Reference
- 12222-000-1016 FDA UDI
- Description
- 250mL Medication Reservoir FDA UDI
Identifiers
- Catalog Number
- AV1016-01 FDA UDI
- Primary DI / UDI-DI
- 17290109152704 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Electric infusion pump administration set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- Not 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
MR Unsafe FDA UDI
AV1016-01 Avoset 250mL Medication Reservoir Pouch by Eitan Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Eitan Medical Ltd
Sources (1)
- FDA UDI 096a41b0-0d62-4dd3-9495-7070bfe76bc4 35 fields · synced May 30, 2026