Catalog Number

-

Brand Name

Alleset

Version/Model Number

Model 19-1071-YL-S

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FNY

Product Code Name

BASIN, EMESIS

Public Device Record Key

171750c6-faa1-404d-8842-e2aca03856a2

Public Version Date

February 12, 2021

Public Version Number

1

DI Record Publish Date

February 04, 2021

Package DI Number

26931918179695

Quantity per Package

20

Contains DI Package

16931918179698

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton