Identity
- Trade Name
- HydroMax HMEF FDA UDI
- Generic Name
- Heat/moisture exchanger/microbial medical gas filter FDA UDI
- Device Name
- HydroMax, Disposable, Heat and Moisture Exchange FDA UDI
- Model / Reference
- HydroMax HMEF - 158250 FDA UDI
- Description
- HydroMax, Disposable, Heat and Moisture Exchange FDA UDI
Identifiers
- Catalog Number
- 158250 FDA UDI
- Primary DI / UDI-DI
- 00817081026719 FDA UDI
- 510(k) Number
- K130664 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Heat/moisture exchanger/microbial medical gas filter
HydroMax HMEF by A-M Systems, 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.
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- Hsiner — Hsiner Company · Class II
Cleared under the same submission
K130664 also covers:
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
- A-M Systems, Inc.
Sources (1)
- FDA UDI 33a38c38-f268-4673-bbaf-02db74126faf 36 fields · synced May 30, 2026