AccessGUDID - DEVICE: Multi-Link™ (10190752182288)

GUDID

Device Identifier (DI) Information

Brand Name: Multi-Link™
Version or Model: 2052133-402
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2052133-402
Company Name: AIRLIFE

Primary DI Number: 10190752182288
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119058668 *Terms of Use

Device Description: Multi-Link™ X2 Single-Patient-Use Long ECG Leadwire Set, 5-Lead Set, Grabber, IEC, 3.6 m/12 ft

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61821	Electrocardiographic lead set, single-use	A collection of noninvasive devices intended 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 is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array to assist electrode placement. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSA	CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -30 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 56c557ca-45e6-4ebb-952a-aea4c9313876
Public Version Date: April 17, 2025
Public Version Number: 5
DI Record Publish Date: March 05, 2021