Identity
- Trade Name
- Resp-O2 (HEPA) Filter FDA UDI
- Generic Name
- Heat/moisture exchanger/microbial medical gas filter FDA UDI
- Device Name
- Bacterial:99.9999%, Viral:99.999%, CO2 Port : Tidal Volume Range(250-1500mL), Media(Pleased Glass Fiber), Dead Space(68mL), Breathing Resistance(2.6cm H2O at 60 L/min), Weight(39g) FDA UDI
- Model / Reference
- 30401 FDA UDI
- Description
- Bacterial:99.9999%, Viral:99.999%, CO2 Port : Tidal Volume Range(250-1500mL), Media(Pleased Glass Fiber), Dead Space(68mL), Breathing Resistance(2.6cm H2O at 60 L/min), Weight(39g) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117305571 FDA UDI
- FDA Product Code
- BYD FDA UDI
- GMDN Term
- Heat/moisture exchanger/microbial medical gas filter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5375 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
Yes
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 (HEPA) Filter by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI a34b8ab5-26a4-4442-b79c-e17228f57935 33 fields · synced Jun 8, 2026