Portex - Smiths Medical International Ltd

Duns Number:215591523

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More Product Details

Catalog Number

-

Brand Name

Portex

Version/Model Number

VP1302

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"

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

-

Product Code Details

Product Code

BSY

Product Code Name

CATHETERS, SUCTION, TRACHEOBRONCHIAL

Device Record Status

Public Device Record Key

b1fe4b51-a726-4311-9d82-05d7a006c9fd

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

October 05, 2016

Additional Identifiers

Package DI Number

30351688433958

Quantity per Package

12

Contains DI Package

10351688433954

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"SMITHS MEDICAL INTERNATIONAL LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 332
2 A medical device with a moderate to high risk that requires special controls. 431