HUDSON RCI - Pressure Line Adaptor - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Pressure Line Adaptor

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More Product Details

Catalog Number

41642

Brand Name

HUDSON RCI

Version/Model Number

IPN044436

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"

-

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

BZA

Product Code Name

CONNECTOR, AIRWAY (EXTENSION)

Device Record Status

Public Device Record Key

9684c8d6-66e7-4451-b922-668d2882a5b8

Public Version Date

October 21, 2020

Public Version Number

4

DI Record Publish Date

September 15, 2018

Additional Identifiers

Package DI Number

24026704390179

Quantity per Package

50

Contains DI Package

04026704390175

Package Discontinue Date

July 23, 2018

Package Status

Not in Commercial Distribution

Package Type

Case

"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