Identity
- Trade Name
- GENOSS Inflator B30 FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, single-use FDA UDI
- Model / Reference
- GBI-B30S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800026507598 FDA UDI
- FDA Product Code
- PTM FDA UDI
- GMDN Term
- Catheter/overtube balloon inflator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Catheter/overtube balloon inflator, single-use
GENOSS Inflator B30 by Genoss — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Genoss
Sources (1)
- FDA UDI c06ab92a-1f98-4b9e-a9e9-2bddf5bf16f2 32 fields · synced Jun 1, 2026