n.a. - i-Bougie - VBM Medizintechnik GmbH

Duns Number:324869601

Device Description: i-Bougie

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More Product Details

Catalog Number

-

Brand Name

n.a.

Version/Model Number

33-70-700-1

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

BSR

Product Code Name

Stylet, Tracheal Tube

Device Record Status

Public Device Record Key

7db2021f-2081-4e72-bd78-3aff4e34081f

Public Version Date

July 20, 2021

Public Version Number

3

DI Record Publish Date

June 24, 2020

Additional Identifiers

Package DI Number

14250105628231

Quantity per Package

1

Contains DI Package

04250105628234

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