Identity
- Trade Name
- Bebeonkers II FDA UDI
- Generic Name
- Surgical/emergency suction cannula, non-illuminating, reusable FDA UDI
- Device Name
- The Bebeonkers II Oral/Nasal Suction Device for the Ultra Preemie infant with Bebe Keeper Kover is intended to be attached to wall suction and used as an oral or nasal cavity evacuator to remove secretions and maintain a clear airway. In between uses the Bebe Keeper Kover can be placed over suction tip to keep clean. Each unit contains one suction tip and one cover. FDA UDI
- Model / Reference
- 16-2KK FDA UDI
- Description
- The Bebeonkers II Oral/Nasal Suction Device for the Ultra Preemie infant with Bebe Keeper Kover is intended to be attached to wall suction and used as an oral or nasal cavity evacuator to remove secretions and maintain a clear airway. In between uses the Bebe Keeper Kover can be placed over suction tip to keep clean. Each unit contains one suction tip and one cover. FDA UDI
Identifiers
- Catalog Number
- 16-2KK FDA UDI
- Primary DI / UDI-DI
- 00815090011382 FDA UDI
- FDA Product Code
- GCX FDA UDI
- GMDN Term
- Surgical/emergency suction cannula, non-illuminating, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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: Surgical/emergency suction cannula, non-illuminating, reusable
Bebeonkers II by Small Beginnings, Inc. — 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
- Small Beginnings, Inc.
Sources (1)
- FDA UDI e9aea60b-e9d8-4458-82a8-f2dfae47d7b9 36 fields · synced May 30, 2026