Jay - The JAY J2 Plus is a pre-contoured foam bariatric - SUNRISE MEDICAL (US) LLC

Duns Number:962525056

Device Description: The JAY J2 Plus is a pre-contoured foam bariatric wheelchair cushion that offers a weight The JAY J2 Plus is a pre-contoured foam bariatric wheelchair cushion that offers a weight capacity of 650 pounds.

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More Product Details

Catalog Number

K0669

Brand Name

Jay

Version/Model Number

J2 Plus

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

IMP

Product Code Name

Cushion, Wheelchair

Device Record Status

Public Device Record Key

b6480c5b-1563-4632-80ac-c6289033d594

Public Version Date

May 20, 2021

Public Version Number

1

DI Record Publish Date

May 12, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUNRISE MEDICAL (US) LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 33
2 A medical device with a moderate to high risk that requires special controls. 18