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Resp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Resp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy FDA UDI
- Generic Name
- Heat/moisture exchanger, single-use FDA UDI
- Device Name
- Bow Tie,Adult : Tidal Volume Range(75-1500mL), Media(Corrugated Paper), Dead Space(12mL), Breathing Resistance(0.2cm H2O at 30L/min), Weight(4.8g) FDA UDI
- Model / Reference
- 30305 FDA UDI
- Description
- Bow Tie,Adult : Tidal Volume Range(75-1500mL), Media(Corrugated Paper), Dead Space(12mL), Breathing Resistance(0.2cm H2O at 30L/min), Weight(4.8g) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117318137 FDA UDI
- FDA Product Code
- BYD FDA UDI
- GMDN Term
- Heat/moisture exchanger, single-use 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, single-use
Resp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy 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 055708a5-d083-4b40-b0cb-7f0835819fe0 33 fields · synced Jun 8, 2026