AccessGUDID - DEVICE: Multi-Link™ (10889483582787)

GUDID

Device Identifier (DI) Information

Brand Name: Multi-Link™
Version or Model: 414370-012
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 414370-012
Company Name: AirLife Finland Oy

Primary DI Number: 10889483582787
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 368457563 *Terms of Use
Previous DI: 10190752180727

Device Description: Multi-Link™ DIN Converter, 12-Lead

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:	No
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?
31683	Electrocardiographic lead switching adaptor	A switching device to which electrocardiograph (ECG) limb and chest leads may be attached. It is used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations (e.g., leads I, II and III). This device will typically be used when the devices to be connected are from different manufacturer's, enabling them to mate together. This is a reusable 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 [?]
K980582	000

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 -22 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c6ff1e49-924f-452a-b95d-0e88ca13a393
Public Version Date: April 03, 2025
Public Version Number: 1
DI Record Publish Date: March 26, 2025