Catalog Number

ADAP-2RL

Brand Name

Safety Adapter

Version/Model Number

ADAP-2RL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

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

DSA

Product Code Name

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

Public Device Record Key

a61807b3-f21a-4d2a-b00d-a75c82bba586

Public Version Date

December 11, 2018

Public Version Number

1

DI Record Publish Date

November 10, 2018

Package DI Number

10813079021992

Quantity per Package

25

Contains DI Package

00813079021995

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Carton