Identity
- Trade Name
- Enteral FDA UDI
- Generic Name
- Vial/bottle adaptor, non-hermetic FDA UDI
- Device Name
- Enteral ISOSAF™ Medicine Bottle Adaptor & Tether FDA UDI
- Model / Reference
- BAISO1 EUDAMEDBAISO0-S EUDAMEDFDA UDI
- Description
- Enteral ISOSAF™ Medicine Bottle Adaptor & Tether FDA UDI
Identifiers
- Catalog Number
- BAISO0-S FDA UDI
- Primary DI / UDI-DI
- 05060590886540 EUDAMEDFDA UDI
- Basic UDI-DI
- 506059088E/OAccessoriesHC 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
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Baiso0-S 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 f37cb2dc-9140-4385-a41e-9390552714a7 61 fields · synced Jun 18, 2026
- FDA UDI 73a45698-30ac-47bd-b15d-a5c77e2ac03f 34 fields · synced May 29, 2026