n.a. - Face Mask; Adult, large - VBM Medizintechnik GmbH

Duns Number:324869601

Device Description: Face Mask; Adult, large

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More Product Details

Catalog Number

-

Brand Name

n.a.

Version/Model Number

35-40-206

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"

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

BSJ

Product Code Name

Mask, Gas, Anesthetic

Device Record Status

Public Device Record Key

ccff26c0-1670-40e7-8bfa-b609105462bd

Public Version Date

September 02, 2020

Public Version Number

1

DI Record Publish Date

August 25, 2020

Additional Identifiers

Package DI Number

14250105600039

Quantity per Package

10

Contains DI Package

04250105600032

Package Discontinue Date

-

Package Status

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