Identity
- Trade Name
- Bioseal Inc. FDA UDI
- Generic Name
- Airway pressure monitor, non-powered FDA UDI
- Device Name
- Hyperinflation System w/Mask FDA UDI
- Model / Reference
- 10558/10 FDA UDI
- Description
- Hyperinflation System w/Mask FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630094105581 FDA UDI
- FDA Product Code
- CAE FDA UDI
- GMDN Term
- Airway pressure monitor, non-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5110 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Category: Airway pressure monitor, non-powered
Bioseal Inc. by Bioseal — 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
- Bioseal
Sources (1)
- FDA UDI 87081ac0-2cad-45ed-8201-65bb7a52c3d1 33 fields · synced Jun 1, 2026