HUDSON RCI - CATH-GUIDE® Oropharyngeal Airways 70 mm - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: CATH-GUIDE® Oropharyngeal Airways 70 mm

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More Product Details

Catalog Number

41169

Brand Name

HUDSON RCI

Version/Model Number

IPN044400

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

CAE

Product Code Name

AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Device Record Status

Public Device Record Key

127d0e0c-7008-4f2c-8f00-e66b4ceeb676

Public Version Date

October 16, 2018

Public Version Number

1

DI Record Publish Date

September 15, 2018

Additional Identifiers

Package DI Number

24026704389845

Quantity per Package

48

Contains DI Package

04026704389841

Package Discontinue Date

July 09, 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