Catalog Number

20301

Brand Name

DLW,5LD,SNAP,INTEL,40",AHA

Version/Model Number

DLW-05AK-40AS-0000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

For Single-Use

Yes

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

97993d23-0a98-4196-a419-f56fb9515ac2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

90840828146770

Quantity per Package

2

Contains DI Package

90840828146756

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-