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Dfine®

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
DFINE® FDA UDI
Generic Name
Electrical-only medical device connection cable, single-use FDA UDI
Model / Reference
00884450374283 FDA UDI

Identifiers

Catalog Number
0860/B FDA UDI
Primary DI / UDI-DI
00884450374283 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Electrical-only medical device connection cable, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Category: Electrical-only medical device connection cable, single-use

This electrical-only medical device connection cable, single-use from Merit Medical Systems, Inc., is a non-patient-contact, insulated, and electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal between medical devices. It is not intended for direct use with patient-worn electrodes, mains power cables, or implantable devices.

Similar devices

Also classified as Electrical-only medical device connection cable, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merit Medical Systems, Inc.

Sources (1)

  • FDA UDI ec37b1b3-3047-4df8-a4d0-157c3e0b239c 33 fields · synced Jul 14, 2026