Portex - SMITHS MEDICAL MD, INC.

Duns Number:106712748

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More Product Details

Catalog Number

-

Brand Name

Portex

Version/Model Number

24-2221-01

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

K965017,K965017

Product Code Details

Product Code

CAZ

Product Code Name

Anesthesia conduction kit

Device Record Status

Public Device Record Key

03b7c85f-7294-46a1-b32d-cb8357762442

Public Version Date

November 17, 2020

Public Version Number

2

DI Record Publish Date

March 09, 2020

Additional Identifiers

Package DI Number

35019517074783

Quantity per Package

10

Contains DI Package

15019517074789

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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