Catalog Number

18121

Brand Name

LDW, 5 LEAD, PINCH, INTELLIVUE, 40", AHA

Version/Model Number

DLA-05BK-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

aef689f0-fe45-41da-ad57-1146c8b21b7b

Public Version Date

August 08, 2019

Public Version Number

1

DI Record Publish Date

July 31, 2019

Package DI Number

90840828173851

Quantity per Package

10

Contains DI Package

90840828157172

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-