Hudson RCI - SOFTECH® Plus ETCO2 Cannula - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: SOFTECH® Plus ETCO2 Cannula

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More Product Details

Catalog Number

2853

Brand Name

Hudson RCI

Version/Model Number

IPN044126

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

K143469,K143469

Product Code Details

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Device Record Status

Public Device Record Key

d5e65e5f-00ad-4da9-9efd-25000b82f57e

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

44026704589812

Quantity per Package

50

Contains DI Package

04026704589814

Package Discontinue Date

-

Package Status

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