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Infuset-1850
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref FP-0010004Model Infuset Flow Control Infusion Set
Identity
- Trade Name
- Infuset-1850 EUDAMEDInfuset FDA UDI
- Generic Name
- Mechanical infusion pump administration set FDA UDI
- Device Name
- Infuset-1850, Flow Control Infusion Set EUDAMEDFDA UDI
- Model / Reference
- Infuset Flow Control Infusion Set EUDAMEDFP-0010004 EUDAMEDInfuset-1850 FDA UDI
- Description
- Infuset-1850, Flow Control Infusion set FDA UDI
Identifiers
- Catalog Number
- FP-0010004 FDA UDI
- Primary DI / UDI-DI
- 00817708020328 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00817708020328 EUDAMED
- 510(k) Number
- K140133 FDA UDI
- FDA Product Code
- FPA FDA UDI
- EMDN Code
- A030104 FLOW REGULATORS EUDAMED
- GMDN Term
- Mechanical infusion pump administration set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Market of Registration
- France 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 6.04 Centimeter FDA UDITotal Volume — 0.10 Milliliter FDA UDI
Infuset-1850 by EMED Technologies Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00817708020328 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- EMED Technologies Corporation
- EUDAMED SRN
- US-MF-000012148
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 33e3d7c2-add2-42d6-9670-ea689795f8b7 61 fields · synced Jun 17, 2026
- FDA UDI 4d25cb6e-df0b-4729-b3d4-cd82395c6088 38 fields · synced May 30, 2026