Thopaz tubing double, large connector - Double Tubing with large connector for thoracic - Medela AG

Duns Number:488293218

Device Description: Double Tubing with large connector for thoracic suction System pump

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More Product Details

Catalog Number

-

Brand Name

Thopaz tubing double, large connector

Version/Model Number

079.0026

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K141553,K141553

Product Code Details

Product Code

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Device Record Status

Public Device Record Key

c0095bd3-0e55-4437-a6af-196c5a81acdb

Public Version Date

June 08, 2021

Public Version Number

7

DI Record Publish Date

June 07, 2017

Additional Identifiers

Package DI Number

07612367042703

Quantity per Package

10

Contains DI Package

07612367042697

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDELA AG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 93