Catalog Number

650-0362-00

Brand Name

TRULINK

Version/Model Number

SUPPLY

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"

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

K954282,K954282

Product Code

DXQ

Product Code Name

blood pressure cuff

Public Device Record Key

6a45a9a8-e2f0-4391-8aed-8fcd1b5a4e0f

Public Version Date

June 07, 2021

Public Version Number

7

DI Record Publish Date

March 14, 2017

Package DI Number

30841522101087

Quantity per Package

5

Contains DI Package

10841522101083

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK