Wheelchair Backpack - Wheelchair Backpack - PRIMO INC

Duns Number:958758146

Device Description: Wheelchair Backpack

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More Product Details

Catalog Number

PM100

Brand Name

Wheelchair Backpack

Version/Model Number

PM100

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

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 Details

Product Code

IKX

Product Code Name

Aid, Transfer

Device Record Status

Public Device Record Key

82cd070e-00f1-4746-a9e8-06bf4f506be7

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

February 27, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRIMO INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 208