Identity
- Trade Name
- 8250 BALLOON VALVE FDA UDI
- Generic Name
- Pulmonary function valve FDA UDI
- Device Name
- 8250 CUSTOM 3W TSHP PET INFBAL FDA UDI
- Model / Reference
- 8250 FDA UDI
- Description
- 8250 CUSTOM 3W TSHP PET INFBAL FDA UDI
Identifiers
- Catalog Number
- CR1922 FDA UDI
- Primary DI / UDI-DI
- 00817136023847 FDA UDI
- FDA Product Code
- BYX FDA UDI
- GMDN Term
- Pulmonary function valve FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5860 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
8250 Balloon Valve by Hans Rudolph, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Hans Rudolph, Inc.
Sources (1)
- FDA UDI e08b15eb-10d1-4d21-905a-e5e64cb75dab 35 fields · synced May 30, 2026