AccessGUDID - DEVICE: Unimed (06945664834735)

GUDID

View all sections | Close all sections

Device Identifier (DI) Information

Brand Name: Unimed
Version or Model: L5-90DP0
Catalog Number:
Company Name: Unimed Medical Supplies, Inc.

Primary DI Number: 06945664834735
Issuing Agency: GS1
Device Count: 1

Device Description: Disposable ECG Lead Wires/D-type/5-lead/grabber/AHA/0.9M/CSM

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Electrocardiographic lead, single-use	A non-sterile device intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It may be designed as: 1) an insulated metal wire(s) with a permanently attached electrode; or 2) an insulated metal wire(s) with a detachable electrode; it is not designed with radiolucent properties. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Electrocardiographic lead, single-use

A non-sterile device intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It may be designed as: 1) an insulated metal wire(s) with a permanently attached electrode; or 2) an insulated metal wire(s) with a detachable electrode; it is not designed with radiolucent properties. This is a single-use device.

FDA Product Code

[?]

Product Code	Product Code Name
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: August 22, 2016
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
16945664834732	10	06945664834735		In Commercial Distribution	carton box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES

DEVICE: Unimed (06945664834735)