HUDSON RCI - TELEFLEX INCORPORATED

Duns Number:002348191

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More Product Details

Catalog Number

81807

Brand Name

HUDSON RCI

Version/Model Number

IPN914330

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

ded1797a-0b9d-4a5b-ae81-7e6d43a3e534

Public Version Date

January 18, 2021

Public Version Number

4

DI Record Publish Date

September 25, 2018

Additional Identifiers

Package DI Number

34026704647027

Quantity per Package

20

Contains DI Package

24026704647020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"TELEFLEX INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3195
2 A medical device with a moderate to high risk that requires special controls. 13747
3 A medical device with high risk that requires premarket approval 3
U Unclassified 26