Montgomery® Initial Cannula Set - Size: 4.Contains one each of 330401 & 341004. - Boston Medical Products, Inc.

Duns Number:131855157

Device Description: Size: 4.Contains one each of 330401 & 341004.

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More Product Details

Catalog Number

330400

Brand Name

Montgomery® Initial Cannula Set

Version/Model Number

330400

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

BTO

Product Code Name

Tube, Tracheostomy (W/Wo Connector)

Device Record Status

Public Device Record Key

b2f239f3-222f-4aa1-a0cc-0a5077b8c661

Public Version Date

August 30, 2022

Public Version Number

3

DI Record Publish Date

September 20, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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