Catalog Number

-

Brand Name

Tubing 2M Single

Version/Model Number

080.0051

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

K150134,K170329,K150134,K170329,K150134,K170329,K150134,K170329

Product Code

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Public Device Record Key

b25cd765-ac43-48a2-b476-795edbc86da0

Public Version Date

May 31, 2022

Public Version Number

8

DI Record Publish Date

June 07, 2017

Package DI Number

07612367007061

Quantity per Package

50

Contains DI Package

07612367051132

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

080.0050