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Exel Dehp-Free Primary Solution Set

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 26085

by Exelint International, Co.

Identity

Trade Name
EXEL DEHP-FREE PRIMARY SOLUTION SET EUDAMED
EXEL 84" Primary Solution Set FDA UDI
Generic Name
Basic intravenous administration set, noninvasive FDA UDI
Device Name
IV Administration Set EUDAMED
Filtered IV Administration Set, 20 drops/ml, Luer Lock, latex-free injection site, 84" tubing FDA UDI
Model / Reference
26085 EUDAMEDFDA UDI
Description
Filtered IV Administration Set, 20 drops/ml, Luer Lock, latex-free injection site, 84" tubing FDA UDI

Identifiers

Catalog Number
26085 FDA UDI
Primary DI / UDI-DI
00020221260854 EUDAMEDFDA UDI
Basic UDI-DI
B-00020221260854 EUDAMED
510(k) Number
K031500 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 EUDAMED
Class II FDA UDI
Regulation Number
880.5440 FDA UDI
Market of Registration
Netherlands 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

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 Dehp-Free Primary Solution Set by Exelint International, Co. — 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

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Manufacturer

Manufacturer
Exelint International, Co.
EUDAMED SRN
US-MF-000037396
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED a6dcec43-0f15-4f77-ae50-844d0a6ab114 61 fields · synced Jun 18, 2026
  • FDA UDI 0ba3f1d5-5f57-4aec-858d-880f0eebe262 35 fields · synced May 30, 2026