n.a. - Catheter Adapter for Manual Suction Pump - VBM Medizintechnik GmbH

Duns Number:324869601

Device Description: Catheter Adapter for Manual Suction Pump

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More Product Details

Catalog Number

-

Brand Name

n.a.

Version/Model Number

30-58-060

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 09, 2022

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"

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 Details

Product Code

GCY

Product Code Name

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Device Record Status

Public Device Record Key

4a16152c-cedb-4677-8c94-864248a67066

Public Version Date

February 10, 2022

Public Version Number

2

DI Record Publish Date

August 26, 2020

Additional Identifiers

Package DI Number

14250105615224

Quantity per Package

10

Contains DI Package

04250105615227

Package Discontinue Date

February 09, 2022

Package Status

Not in Commercial Distribution

Package Type

-

"VBM MEDIZINTECHNIK GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 334
2 A medical device with a moderate to high risk that requires special controls. 14