Nasal Trumpet - 1ea - sterile, pre-lubricated nasopharyngeal - Safeguard US Operating, LLC

Duns Number:118492643

Device Description: 1ea - sterile, pre-lubricated nasopharyngeal airway

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More Product Details

Catalog Number

11-128

Brand Name

Nasal Trumpet

Version/Model Number

02

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 07, 2029

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

Yes

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

b45f6a8f-01b4-43ef-a533-0f14ed488265

Public Version Date

August 19, 2022

Public Version Number

3

DI Record Publish Date

April 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAFEGUARD US OPERATING, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 217
2 A medical device with a moderate to high risk that requires special controls. 48