Identity
- Trade Name
- Aerotech I Radioaerosol Administration System FDA UDI
- Generic Name
- Radioaerosol administration set FDA UDI
- Device Name
- AeroTech I Shield FDA UDI
- Model / Reference
- 177-095 FDA UDI
- Description
- AeroTech I Shield FDA UDI
Identifiers
- Catalog Number
- 177-095 FDA UDI
- Primary DI / UDI-DI
- 00718175087633 FDA UDI
- 510(k) Number
- K800023 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radioaerosol administration set
Aerotech I Radioaerosol Administration System by Biodex Medical Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radioaerosol administration set.
- Patient Administration Set — CYCLOMEDICA AUSTRALIA PTY LTD · Class II
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- Aero/Vent Plus — MEDI NUCLEAR CORP., INC. · Class II
- Insta/Vent — MEDI NUCLEAR CORP., INC. · Class II
- Aero/Vent Jr. — MEDI NUCLEAR CORP., INC. · Class II
- Insta/Vent — MEDI NUCLEAR CORP., INC. · Class II
Cleared under the same submission
K800023 also covers:
- Aerotech I Radioaerosol Administration System — Biodex Medical Systems
- Aerotech I Radioaerosol Administration System — Biodex Medical Systems
- AeroTech I Convenience Kit, Small Particle — MIRION TECHNOLOGIES (CAPINTEC), INC
- AeroTech I Convenience Kit, Standard — MIRION TECHNOLOGIES (CAPINTEC), INC
- AeroTech I Convenience Kit, Venti Pak — MIRION TECHNOLOGIES (CAPINTEC), INC
- AeroTech I Shield — MIRION TECHNOLOGIES (CAPINTEC), INC
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 1ce34115-c4f5-4f30-9d52-849ca3e577a5 35 fields · synced Jun 8, 2026