Medex - SMITHS MEDICAL ASD, INC.

Duns Number:828611934

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More Product Details

Catalog Number

-

Brand Name

Medex

Version/Model Number

MX20885R1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 23, 2020

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

DRS

Product Code Name

TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Device Record Status

Public Device Record Key

724bcaf5-52e5-4b0d-9c95-59e7616de356

Public Version Date

October 23, 2020

Public Version Number

5

DI Record Publish Date

December 30, 2016

Additional Identifiers

Package DI Number

50351688508612

Quantity per Package

10

Contains DI Package

10351688508614

Package Discontinue Date

October 23, 2020

Package Status

Not in Commercial Distribution

Package Type

Case

"SMITHS MEDICAL ASD, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 104
2 A medical device with a moderate to high risk that requires special controls. 36112