POSEY - ROLL GUARD REPLACEMENT - POSEY PRODUCTS, LLC

Duns Number:008503294

Device Description: ROLL GUARD REPLACEMENT

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More Product Details

Catalog Number

5701

Brand Name

POSEY

Version/Model Number

5701

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FNL

Product Code Name

Bed, Ac-Powered Adjustable Hospital

Device Record Status

Public Device Record Key

1d67ef77-c3da-4305-9df5-00b6e1a574e1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 13, 2016

Additional Identifiers

Package DI Number

20190676000054

Quantity per Package

6

Contains DI Package

10190676000057

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"POSEY PRODUCTS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 177
2 A medical device with a moderate to high risk that requires special controls. 77