Catalog Number

20041

Brand Name

SOMAVAC Belt

Version/Model Number

20041

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180606,K180606

Product Code

GCY

Product Code Name

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Public Device Record Key

db2924b3-9d6c-49ef-8baf-844db5ac2c9d

Public Version Date

April 21, 2021

Public Version Number

3

DI Record Publish Date

November 08, 2019

Package DI Number

10850004219055

Quantity per Package

1

Contains DI Package

00850004219058

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box