Catalog Number

Yes

Brand Name

tellihealth

Version/Model Number

U30B

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

-

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

INF

Product Code Name

Scale, Platform, Wheelchair

Public Device Record Key

ef87553e-b567-44c9-af73-4867e302ca8c

Public Version Date

June 13, 2022

Public Version Number

1

DI Record Publish Date

June 03, 2022

Package DI Number

16953825905924

Quantity per Package

5

Contains DI Package

06953825905927

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton