Portex - Smiths Medical International Ltd

Duns Number:215591523

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More Product Details

Catalog Number

-

Brand Name

Portex

Version/Model Number

101/541/090

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

K173912,K173912,K173912

Product Code Details

Product Code

BTO

Product Code Name

Tube, tracheostomy (w/wo connector)

Device Record Status

Public Device Record Key

b2f98bee-9f63-449e-bbd1-3555bd2cb7b8

Public Version Date

December 25, 2019

Public Version Number

1

DI Record Publish Date

December 17, 2019

Additional Identifiers

Package DI Number

35019517103322

Quantity per Package

1

Contains DI Package

15019517103328

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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