Identity
- Trade Name
- Micro-Vent FDA UDI
- Generic Name
- Radioaerosol administration set FDA UDI
- Device Name
- Micro-Vent Radioaerosol System FDA UDI
- Model / Reference
- 177-107 FDA UDI
- Description
- Micro-Vent Radioaerosol System FDA UDI
Identifiers
- Catalog Number
- 177-107 FDA UDI
- Primary DI / UDI-DI
- 00718175001073 FDA UDI
- 510(k) Number
- K904717 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Radioaerosol administration set 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radioaerosol administration set
Micro-Vent by Biodex Medical Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Aero/Vent Jr. — MEDI NUCLEAR CORP., INC. · Class II
- Insta/Vent — MEDI NUCLEAR CORP., INC. · 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 |
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Manufacturer
- Manufacturer
- Biodex Medical Systems
Sources (1)
- FDA UDI 080788a2-d6ba-4c55-8221-14f4d6d3124a 35 fields · synced May 30, 2026