Identity
- Trade Name
- My Resp-O2 Penguin Compressor Nebulizer FDA UDI
- Generic Name
- Therapeutic agent nebulizer, benchtop FDA UDI
- Model / Reference
- 34405 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117308794 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Therapeutic agent nebulizer, benchtop FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Therapeutic agent nebulizer, benchtop
My Resp-O2 Penguin Compressor Nebulizer by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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K091272 also covers:
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- NEBULIZER BOTTLE DISPOSABLE 6CC; — BESMED HEALTH BUSINESS CORP.
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- NEBULIZER SET 20CC W/T-PIECE, MOUTH PIECE — BESMED HEALTH BUSINESS CORP.
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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 2687a339-26e6-404e-bde4-837682b59fcc 33 fields · synced Jun 6, 2026