Identity
- Trade Name
- Enteral FDA UDI
- Generic Name
- Vial/bottle adaptor, non-hermetic FDA UDI
- Device Name
- Enteral, ENFit® Accessories, Bottle Adaptor, Single Use Size 3.5 – 19 – 23mm FDA UDI
- Model / Reference
- BAISO1 EUDAMEDBAISO35 EUDAMEDFDA UDI
- Description
- Enteral, ENFit® Accessories, Bottle Adaptor, Single Use Size 3.5 – 19 – 23mm FDA UDI
Identifiers
- Catalog Number
- BAISO35 FDA UDI
- Primary DI / UDI-DI
- 05060460848074 EUDAMEDFDA UDI
- Basic UDI-DI
- 506059088E/OAccessoriesHC EUDAMED
- Unit of Use DI
- 05060460848081 EUDAMED
- FDA Product Code
- KYX FDA UDI
- EMDN Code
- A070199 ADAPTERS AND CONNECTORS - OTHER EUDAMED
- GMDN Term
- Vial/bottle adaptor, non-hermetic FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6430 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Baiso35 by GBUK Group — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506059088E/OAccessoriesHC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GBUK Group
- EUDAMED SRN
- GB-MF-000002238
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (2)
- EUDAMED f005a7e2-3394-43b6-a8e2-8c6c47483a16 61 fields · synced Jul 14, 2026
- FDA UDI b5ac5950-2c5d-47be-a8ce-142d8b7a75d0 34 fields · synced May 30, 2026