Collecting Bag 2000ml (Straub Medical®) - The collecting bag is non-patient contacting and - Straub Medical AG

Duns Number:488489766

Device Description: The collecting bag is non-patient contacting and is attached to the silicon outflow tube o The collecting bag is non-patient contacting and is attached to the silicon outflow tube on the proximal end of the catheter. The fluid aspirated by the catheter passes through the catheters’ outflow tubing into the Collecting bag.

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More Product Details

Catalog Number

10170

Brand Name

Collecting Bag 2000ml (Straub Medical®)

Version/Model Number

Version 1.0

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

-

Product Code Details

Product Code

KNX

Product Code Name

Collector, Urine, (And Accessories) For Indwelling Catheter

Device Record Status

Public Device Record Key

3a30fe23-eb0a-45a3-82d8-6ec76fe85264

Public Version Date

January 08, 2021

Public Version Number

3

DI Record Publish Date

January 31, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRAUB MEDICAL AG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 34