Identity
- Trade Name
- Emergent Respiratory FDA UDI
- Generic Name
- Portable pneumatic ventilator FDA UDI
- Device Name
- PortO2 Vent CPAP FDA UDI
- Model / Reference
- 1900-001 FDA UDI
- Description
- PortO2 Vent CPAP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850071887242 FDA UDI
- 510(k) Number
- K021520 FDA UDI
- FDA Product Code
- BTL FDA UDI
- GMDN Term
- Portable pneumatic ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5925 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Portable pneumatic ventilator
Emergent Respiratory by Mdl Solutions Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
- Percussionaire — Percussionaire Corporation · Class II
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Cleared under the same submission
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
- Mdl Solutions Incorporated
Sources (1)
- FDA UDI 37809bd7-abcb-4f28-9c3d-a0594e0e6e9d 35 fields · synced May 31, 2026