Catalog Number

TRUGUARD

Brand Name

TRUVUE

Version/Model Number

REV00

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 03, 2020

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

FMP

Product Code Name

Protector, Skin Pressure

Public Device Record Key

11055ef0-4ae5-49bc-913b-c1a3351fe711

Public Version Date

September 04, 2020

Public Version Number

2

DI Record Publish Date

August 21, 2020

Package DI Number

30603354600615

Quantity per Package

6

Contains DI Package

10603354600604

Package Discontinue Date

September 03, 2020

Package Status

Not in Commercial Distribution

Package Type

Box