RUSCH - Nasopharyngeal airway - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Nasopharyngeal airway

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More Product Details

Catalog Number

125200-000360

Brand Name

RUSCH

Version/Model Number

IPN042346

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

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

BTQ

Product Code Name

AIRWAY, NASOPHARYNGEAL

Device Record Status

Public Device Record Key

a138dabc-1559-490b-8ef9-c2b9a4234fab

Public Version Date

October 16, 2018

Public Version Number

1

DI Record Publish Date

September 15, 2018

Additional Identifiers

Package DI Number

44026704015090

Quantity per Package

266

Contains DI Package

24026704015096

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