Portex - SMITHS MEDICAL MD, INC.

Duns Number:106712748

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More Product Details

Catalog Number

-

Brand Name

Portex

Version/Model Number

100/166/060

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

K790312,K790312,K790312

Product Code Details

Product Code

BTR

Product Code Name

Tube, tracheal (w/wo connector)

Device Record Status

Public Device Record Key

c95ecbca-43f8-400c-8472-6799a7c47399

Public Version Date

December 01, 2020

Public Version Number

5

DI Record Publish Date

September 01, 2015

Additional Identifiers

Package DI Number

55019315054066

Quantity per Package

12

Contains DI Package

35019315054062

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pallet

"SMITHS MEDICAL MD, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 686
3 A medical device with high risk that requires premarket approval 2
U Unclassified 1