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Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000 CO2 Port, Low Profile
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000 CO2 Port, Low Profile FDA UDI
- Generic Name
- Heat/moisture exchanger/microbial medical gas filter FDA UDI
- Device Name
- Adult, Tidal Volume Range( 150-1000mL), Media (Foam+ Flat Media), Dead Space (43mL), Breathing Resistance (1.9cm H2O at 60L /min), Weight (21g) FDA UDI
- Model / Reference
- 30104 FDA UDI
- Description
- Adult, Tidal Volume Range( 150-1000mL), Media (Foam+ Flat Media), Dead Space (43mL), Breathing Resistance (1.9cm H2O at 60L /min), Weight (21g) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117305311 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Heat/moisture exchanger/microbial medical gas filter
Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000 CO2 Port, Low Profile by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Heat/moisture exchanger/microbial medical gas filter.
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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
- Dynarex Corp.
Sources (1)
- FDA UDI 4c11eea0-a250-4e8b-b87b-1f4c0c2dbcd2 33 fields · synced May 31, 2026