Stabiltube - Long Term Endotracheal Tube Holders, 20 units - B&B Medical Technologies

Duns Number:829743579

Device Description: Long Term Endotracheal Tube Holders, 20 units

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More Product Details

Catalog Number

11065

Brand Name

Stabiltube

Version/Model Number

11065

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

CBH

Product Code Name

Device, Fixation, Tracheal Tube

Device Record Status

Public Device Record Key

99391167-0b97-4120-bc3b-8b1f1809692b

Public Version Date

November 27, 2019

Public Version Number

2

DI Record Publish Date

November 08, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"B&B MEDICAL TECHNOLOGIES" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 6