Identity
- Trade Name
- Aero-Pro HEPA Light Machine FDA UDI
- Generic Name
- Heat/moisture exchanger/microbial medical gas filter FDA UDI
- Model / Reference
- 201022 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841470110055 FDA UDI
- 510(k) Number
- K013122 FDA UDI
- FDA Product Code
- CAH FDA UDI
- GMDN Term
- Heat/moisture exchanger/microbial medical gas filter 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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Heat/moisture exchanger/microbial medical gas filter
Aero-Pro HEPA Light Machine by Pulmodyne Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heat/moisture exchanger/microbial medical gas filter.
- Ulti-MistHME/F Angled — KING SYSTEMS CORPORATION. · Class II
- AirLife™ — Airlife, Inc. · Class I
- DAR — Covidien LP · Class I
- Disposable Anesthesia Circuit — WESTMED, INC. · Class I
- ThermoShield Adult Bacterial Viral HMEF — FLEXICARE MEDICAL LIMITED · Class II
- Hygrovent Gold Comfort — FLEXICARE MEDICAL LIMITED · Class II
- Typenex Heat and Moisture Exchanger — Typenex Medical, LLC · Class II
- Hsiner — Hsiner Company · Class II
Cleared under the same submission
K013122 also covers:
- Aero-Pro — Engineered Medical Systems, LLC
- Aero-Pro — Engineered Medical Systems, LLC
- Aero-Sat — Engineered Medical Systems, LLC
- Aero-Sat — Engineered Medical Systems, LLC
- Aero-Sat — Engineered Medical Systems, LLC
- Aero-Sat — Engineered Medical Systems, LLC
- Bacterial/Viral Filter — Engineered Medical Systems, LLC
- Aero-Pro — Pulmodyne Inc.
- Aero-Pro Filter Compact Angled — Pulmodyne Inc.
- Aero-Pro Filter Small Angled — Pulmodyne Inc.
- Aero-Pro Filter Small Straight — Pulmodyne Inc.
- Aero-Pro S Filter — Pulmodyne 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pulmodyne Inc.
Sources (1)
- FDA UDI d4ddbba4-0fbf-4b9d-95b4-9641e8a23647 33 fields · synced Jun 8, 2026