Catalog Number

2221

Brand Name

ADDTO

Version/Model Number

2221

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"

Yes

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

GCE

Product Code Name

Adaptor, Catheter

Public Device Record Key

98a04550-2651-4ffc-a7fd-a1050e8b92fa

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

July 15, 2020

Package DI Number

00860001236040

Quantity per Package

100

Contains DI Package

00860001236019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box