HUDSON RCI - ET TUBE,HVT,7.0,NOVA PLUS - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: ET TUBE,HVT,7.0,NOVA PLUS

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More Product Details

Catalog Number

V5-10314

Brand Name

HUDSON RCI

Version/Model Number

IPN046758

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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"

Yes

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

K822082,K822082,K822082

Product Code Details

Product Code

BTR

Product Code Name

Tube, tracheal (w/wo connector)

Device Record Status

Public Device Record Key

6e369cc6-1dc8-4448-befe-85444710ae35

Public Version Date

February 15, 2022

Public Version Number

8

DI Record Publish Date

October 16, 2015

Additional Identifiers

Package DI Number

24026704588774

Quantity per Package

10

Contains DI Package

04026704588770

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"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