Identity
- Trade Name
- EXEL 20" EXTENSION SET, W/LUER SLIP EUDAMEDEXEL 20" IV Extension Set EUDAMEDAdvance Plus Universal IV Administration Set FDA UDI
- Generic Name
- Basic intravenous administration set, noninvasive FDA UDI
- Device Name
- IV Extension Set EUDAMEDEXEL IV Extension Set EUDAMEDIV Administration Set, Luer Lock/Slip, 20" tubing FDA UDI
- Model / Reference
- 1720 EUDAMEDFDA UDI
- Description
- IV Administration Set, Luer Lock/Slip, 20" tubing FDA UDI
Identifiers
- Catalog Number
- 1720 FDA UDI
- Primary DI / UDI-DI
- 00020221017205 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221017205 EUDAMED20221IVEXT0179U EUDAMED
- 510(k) Number
- K092172 FDA UDI
- FDA Product Code
- FPA FDA UDI
- EMDN Code
- A03020101 LOW PRESSURE EXTENSION LINES EUDAMED
- GMDN Term
- Basic intravenous administration set, noninvasive FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Exel 20" Extension Set, W/Luer Slip by Exelint International, Co. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00020221017205 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00020221017205 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 d5f8c238-a605-404e-9a3e-2517203f8f6e 61 fields · synced Jul 13, 2026
- FDA UDI b9c58f0f-c3f0-49a2-9c10-942fa4ea2026 35 fields · synced May 30, 2026
- EUDAMED 55957016-7a29-4d9c-b52e-430afde2f00a 61 fields · synced Jul 9, 2026