Identity
- Trade Name
- UNBRANDED FDA UDI
- Generic Name
- Fluid transfer set, general-purpose FDA UDI
- Device Name
- Bottle Decanter EUDAMEDDecanter FDA UDI
- Model / Reference
- 10-104 EUDAMEDFDA UDI
- Description
- Decanter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848340000010 EUDAMEDFDA UDI
- Basic UDI-DI
- 8483400010-104LD EUDAMED
- FDA Product Code
- KPE FDA UDI
- EMDN Code
- A0699 DRAINAGE AND FLUID COLLECTION DEVICES - OTHER EUDAMED
- GMDN Term
- Fluid transfer set, general-purpose FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5025 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Bottle Decanter by Advance Medical Designs, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K852778 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 8483400010-104LD | Class I | Active |
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Manufacturer
- Manufacturer
- Advance Medical Designs, Inc.
- EUDAMED SRN
- US-MF-000009790
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 893fb540-5b47-47d2-b697-0097dc706ee9 61 fields · synced Oct 6, 2026
- FDA UDI dac5eee9-8bd4-4e33-b58b-6f5f521e1ebb 33 fields · synced May 30, 2026
- FDA 510(k) K852778 1 fields · synced May 18, 2026