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RxCrush

EUDAMEDFDA UDI

Class I (EU MDR)

Ref EL02 Female ENFit® to Female Luer Lock Adapter - Screw-on

by Resolve Designs LLC

Identity

Trade Name
RxCrush EUDAMEDFDA UDI
Generic Name
ENFit/Luer linear connector FDA UDI
Device Name
ENFit Adapter EUDAMED
Female ENFit to Female Luer Lock Adapter - Screw-on. Connects male ENFit (e.g. RxCrush Pouch) to male Luer syringe. FDA UDI
Model / Reference
EL02 Female ENFit® to Female Luer Lock Adapter - Screw-on EUDAMED
EL02-100 FDA UDI
Description
Female ENFit to Female Luer Lock Adapter - Screw-on. Connects male ENFit (e.g. RxCrush Pouch) to male Luer syringe. FDA UDI

Identifiers

Catalog Number
EL02 FDA UDI
Primary DI / UDI-DI
00850006611126 EUDAMEDFDA UDI
Basic UDI-DI
0850006611AD67 EUDAMED
Direct Marketing DI
00850006611126 EUDAMED
FDA Product Code
KYX FDA UDI
EMDN Code
A088099 NUTRITION AND INFUSION BAGS AND CONTAINERS, SINGLE-USE - OTHER ACCESSORIES EUDAMED
GMDN Term
ENFit/Luer linear connector FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
880.6430 FDA UDI
Market of Registration
Spain EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

RxCrush by Resolve Designs LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Resolve Designs LLC
EUDAMED SRN
US-MF-000017382
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (2)

  • EUDAMED b01a679e-3e52-479c-9d50-bdefb5d1e542 61 fields · synced Aug 1, 2026
  • FDA UDI 9ffe1dcd-e8a1-41b3-bc72-141f9924cf17 36 fields · synced May 30, 2026