Identity
- Trade Name
- Aerobiotix FDA UDI
- Generic Name
- Surgical laminar airflow unit FDA UDI
- Device Name
- Air purification machine vac intake hose FDA UDI
- Model / Reference
- AeroCure VAC+ Intake Arm FDA UDI
- Description
- Air purification machine vac intake hose FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852348007186 FDA UDI
- FDA Product Code
- FZH FDA UDI
- GMDN Term
- Surgical laminar airflow unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5070 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
Similar devices
Also classified as Surgical laminar airflow unit.
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- Illuvia — AEROBIOTIX, INC. · Class II
- 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 e4cf2797-2bbb-45c5-8f29-7b671fe1deb7 34 fields · synced May 30, 2026