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Transfer Device
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 10-108510(k) K853188
Identity
- Trade Name
- UNBRANDED FDA UDI
- Generic Name
- Fluid transfer set, general-purpose FDA UDI
- Device Name
- Transfer Device EUDAMEDDecanter FDA UDI
- Model / Reference
- 10-108 EUDAMEDFDA UDI
- Description
- Decanter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848340000034 EUDAMEDFDA UDI
- Basic UDI-DI
- 8483400010-108LM EUDAMED
- FDA Product Code
- LHI 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
- 880.5440 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
Transfer Device 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 | K853188 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 8483400010-108LM | 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 ab2a2147-2fa7-4044-a407-84c71342305c 85 fields · synced Jun 18, 2026
- FDA UDI b2f709b5-c8a5-49e5-b93a-091aba6ee577 33 fields · synced May 30, 2026
- FDA 510(k) K853188 1 fields · synced May 18, 2026