Trach Tube Cleaning Brushes - Size: 6 - Boston Medical Products, Inc.

Duns Number:131855157

Device Description: Size: 6

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More Product Details

Catalog Number

3306

Brand Name

Trach Tube Cleaning Brushes

Version/Model Number

3306

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

EPE

Product Code Name

Brush, Cleaning, Tracheal Tube

Device Record Status

Public Device Record Key

2102f3e8-b727-4a7d-87e2-1ac4c54c095b

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

September 30, 2022

Additional Identifiers

Package DI Number

34063107102685

Quantity per Package

10

Contains DI Package

14063107102681

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"BOSTON MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 121
2 A medical device with a moderate to high risk that requires special controls. 211
U Unclassified 1