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EXEL 105" IV ADMIN SET, 15 DROP W/ 2 Y INJECTION SITES, 2 OmLLUSION CLAMPS, ROL…
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 29088
Identity
- Trade Name
- EXEL 105" IV ADMIN SET, 15 DROP W/ 2 Y INJECTION SITES, 2 OmLLUSION CLAMPS, ROLLER CLAMP AND SLIP-LOCK CONNECTOR EUDAMEDEXEL IV Administration Set, Vented/Non-Vented with 2 (Y) Injection Sites, 2 Occlusion Clamps, Roller Clamp, 105" Tubing, 15 Drop/mL Slip/Lock Connector EUDAMEDEXEL I.V. Administration Set FDA UDI
- Generic Name
- Basic intravenous administration set, noninvasive FDA UDI
- Device Name
- IV Administration Set EUDAMEDEXEL IV Administration Set EUDAMEDI.V. Administration Set, 15 drops/ml, Lock/Slip, 2 Injection Sites, Roller Clamp, 2 Occlusion Clamps, Vented/Non Vented, 105" Tubing FDA UDI
- Model / Reference
- 29088 EUDAMEDFDA UDI
- Description
- I.V. Administration Set, 15 drops/ml, Lock/Slip, 2 Injection Sites, Roller Clamp, 2 Occlusion Clamps, Vented/Non Vented, 105" Tubing FDA UDI
Identifiers
- Catalog Number
- 29088 FDA UDI
- Primary DI / UDI-DI
- 00020221290882 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221290882 EUDAMED20221IVADM270Y6 EUDAMED
- 510(k) Number
- K010404 FDA UDI
- FDA Product Code
- FPA FDA UDI
- EMDN Code
- A03040199 INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Basic intravenous administration set, noninvasive FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Market of Registration
- Belgium EUDAMEDAustria 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
Yes
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
No
FDA UDI
EXEL 105" IV ADMIN SET, 15 DROP W/ 2 Y INJECTION SITES, 2 OmLLUSION CLAMPS, ROL… by Exelint International, Co. — Class IIa — MDR, MDD, FDA UDI — listed in…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00020221290882 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00020221290882 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Exelint International, Co.
- EUDAMED SRN
- US-MF-000037396
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED badaab86-9a55-46cc-af04-06e1d99d6a20 61 fields · synced Oct 6, 2026
- FDA UDI 0e658d92-a748-4c52-b385-cc5ef53c4f28 35 fields · synced May 30, 2026
- EUDAMED e76201f6-7bda-482d-97db-c172451cdcc1 61 fields · synced Jul 26, 2026