Identity
- Trade Name
- Aero-Sat FDA UDI
- Generic Name
- Heat/moisture exchanger/microbial medical gas filter FDA UDI
- Model / Reference
- 301-424 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841470108076 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Heat/moisture exchanger/microbial medical gas filter
Aero-Sat by Engineered Medical Systems, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Heat/moisture exchanger/microbial medical gas filter.
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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
- 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 HEPA Light Machine — 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
- Engineered Medical Systems, LLC
Sources (1)
- FDA UDI 1919febc-856f-44a5-aafa-2351ca4c0039 33 fields · synced May 30, 2026