Identity
- Trade Name
- Aero-Pro HEPA Small Angled FDA UDI
- Generic Name
- Microbial medical gas filter, single-use FDA UDI
- Model / Reference
- 20151 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841470110017 FDA UDI
- FDA Product Code
- CAH FDA UDI
- GMDN Term
- Microbial medical gas filter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5260 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Microbial medical gas filter, single-use
Aero-Pro HEPA Small Angled by Pulmodyne Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microbial medical gas filter, single-use.
- ECO slimline — GVS Filter Technology UK Ltd · Class IIa
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- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- Ventlab — Ventlab Corp. · Class II
- Disposable Heat and Moisture Exchanger Filters — NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD · Class IIa
- Ventlab — Ventlab Corp. · Class II
- Pentair — Pentair Filtration Solutions · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · 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
- Pulmodyne Inc.
Sources (1)
- FDA UDI fc4231e4-602d-4792-a372-7a7e78efa794 32 fields · synced Jun 8, 2026