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Resp-O2 Heat Moisture Exchanger (HME) 1500 With Integrated Flex Tube
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Resp-O2 Heat Moisture Exchanger (HME) 1500 With Integrated Flex Tube FDA UDI
- Generic Name
- Heat/moisture exchanger, single-use FDA UDI
- Device Name
- Tidal Volume Range(250-1500mL), Media(Foam), Dead Space(90mL), Breathing Resistance (1.6cm H2O at 60 L/min), Weight(15.5g). Adult/Pediatric FDA UDI
- Model / Reference
- 30202 FDA UDI
- Description
- Tidal Volume Range(250-1500mL), Media(Foam), Dead Space(90mL), Breathing Resistance (1.6cm H2O at 60 L/min), Weight(15.5g). Adult/Pediatric FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117318090 FDA UDI
- FDA Product Code
- CAH FDA UDI
- GMDN Term
- Heat/moisture exchanger, single-use 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
No
FDA UDI
Category: Heat/moisture exchanger, single-use
Resp-O2 Heat Moisture Exchanger (HME) 1500 With Integrated Flex Tube by Dynarex Corp. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI 095bff03-e8f3-4fd7-b87b-9f7f101145fb 33 fields · synced Jun 8, 2026