Catalog Number

1085

Brand Name

VALVED TEE ADAPTER

Version/Model Number

1085

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BZO

Product Code Name

Set, Tubing And Support, Ventilator (W Harness)

Public Device Record Key

e2556193-4c83-4fc4-b247-70a43cf94ab7

Public Version Date

October 21, 2020

Public Version Number

4

DI Record Publish Date

September 14, 2018

Package DI Number

10383480000041

Quantity per Package

50

Contains DI Package

00383480000044

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE