Catalog Number

5808PV

Brand Name

Pkit, STS Trios, LPV, SG Arm Pad

Version/Model Number

5808PV-1

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KME

Product Code Name

Bedding, Disposable, Medical

Public Device Record Key

78903b05-4a51-4541-a3d6-8f384d909725

Public Version Date

September 06, 2021

Public Version Number

3

DI Record Publish Date

April 24, 2018

Package DI Number

20842430101773

Quantity per Package

3

Contains DI Package

00842430101779

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case