Identity
- Trade Name
- USV 2010 FDA UDI
- Generic Name
- Ultrasonic nebulizing system FDA UDI
- Device Name
- SU99 für WestPrime FDA UDI
- Model / Reference
- 2010-80-0-000-00 FDA UDI
- Description
- SU99 für WestPrime FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260217220028 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Ultrasonic nebulizing system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ultrasonic nebulizing system
Usv 2010 by AMTRION GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasonic nebulizing system.
- I neb — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
- Lamira — PARI RESPIRATORY EQUIPMENT, INC. · Class II
- Lamira — PARI RESPIRATORY EQUIPMENT, INC. · Class II
- eRapid — PARI RESPIRATORY EQUIPMENT, INC. · Class II
- I-NEB — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
- I-neb In Vitro Test Disc Power 10 — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
- I-neb — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
- I-neb — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
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
- AMTRION GmbH
Sources (1)
- FDA UDI ffaa6ca0-6954-43e0-91ec-8d6ba0c350ad 34 fields · synced May 31, 2026