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EXEL IV SET 15 DRP/mL, W/Y SITE, VENT/NON-VENT, 78" TUBE, LL
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 29082
Identity
- Trade Name
- EXEL IV SET 15 DRP/mL,W/Y SITE,VENT/NON-VENT,78" TUBE, LL EUDAMEDEXEL IV Administration Set, Vented/Non-Vented with (Y) Injection Site, 78" Tubing, 15 Drop/mL Luer Lock 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, Luer Lock, with Y-injection Site, Vented/Non Vented, with Clamp, 78" Tubing FDA UDI
- Model / Reference
- 29082 EUDAMEDFDA UDI
- Description
- I.V. Administration Set, 15 drops/ml, Luer Lock, with Y-injection Site, Vented/Non Vented, with Clamp, 78" Tubing FDA UDI
Identifiers
- Catalog Number
- 29082 FDA UDI
- Primary DI / UDI-DI
- 00020221290820 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221290820 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 IV SET 15 DRP/mL, W/Y SITE, VENT/NON-VENT, 78" TUBE, LL by Exelint International, Co. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-00020221290820 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00020221290820 | 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 091314a1-27ad-44fa-94eb-a729dbbb28f1 61 fields · synced Oct 6, 2026
- FDA UDI 28bce093-7083-47d4-9cab-7be17e8e2743 35 fields · synced May 30, 2026
- EUDAMED 2746c74c-fa51-4204-bb64-5c0c60399190 61 fields · synced Aug 3, 2026