Identity
- Trade Name
- Aerobiotix FDA UDI
- Generic Name
- Surgical laminar airflow unit FDA UDI
- Device Name
- Air purification machine vac hose FDA UDI
- Model / Reference
- AeroCure Vac Hose XL FDA UDI
- Description
- Air purification machine vac hose FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852348007438 FDA UDI
- FDA Product Code
- FRA FDA UDI
- GMDN Term
- Surgical laminar airflow unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6500 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical laminar airflow unit
Aerobiotix by Aerobiotix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Aerobiotix — AEROBIOTIX, INC. · Class II
- Aerobiotix — AEROBIOTIX, INC. · Class II
- Illuvia — AEROBIOTIX, INC. · Class II
- Illuvia — AEROBIOTIX, INC. · Class II
- Illuvia — AEROBIOTIX, 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
- Aerobiotix, Inc.
Sources (1)
- FDA UDI 801f17a8-1399-4c1c-91a5-f01dc937c14f 34 fields · synced Jun 6, 2026