Multi-Link™ - X2 ECG Reusable Trunk Cable - VYAIRE MEDICAL, INC.

Duns Number:080456871

Device Description: X2 ECG Reusable Trunk Cable

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More Product Details

Catalog Number

2090200-084

Brand Name

Multi-Link™

Version/Model Number

2090200-084

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

DSA

Product Code Name

CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Device Record Status

Public Device Record Key

841ba853-df8a-4e80-b4ab-12d139442445

Public Version Date

March 17, 2021

Public Version Number

1

DI Record Publish Date

March 09, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VYAIRE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1068
2 A medical device with a moderate to high risk that requires special controls. 780
3 A medical device with high risk that requires premarket approval 65
U Unclassified 1