PROBASICS - SHOWER CHAIR WITH BACK - COMPASS HEALTH BRANDS CORP.

Duns Number:827221698

Device Description: SHOWER CHAIR WITH BACK

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More Product Details

Catalog Number

-

Brand Name

PROBASICS

Version/Model Number

BSCWB

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

ILS

Product Code Name

Adaptor, Hygiene

Device Record Status

Public Device Record Key

ee3b4de9-8946-426b-9551-94d0cd1d6106

Public Version Date

February 04, 2021

Public Version Number

1

DI Record Publish Date

January 27, 2021

Additional Identifiers

Package DI Number

30815067071914

Quantity per Package

4

Contains DI Package

00815067071913

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARDBOARD BOX

"COMPASS HEALTH BRANDS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 62
2 A medical device with a moderate to high risk that requires special controls. 273
U Unclassified 2