Portex - Smiths Medical ASD, Inc.

Duns Number:082005361

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More Product Details

Catalog Number

-

Brand Name

Portex

Version/Model Number

24-1014-64

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

K172823,K172823

Product Code Details

Product Code

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Device Record Status

Public Device Record Key

5ad710e2-a77a-4bc2-87ab-65e7fb295ef0

Public Version Date

March 17, 2020

Public Version Number

1

DI Record Publish Date

March 09, 2020

Additional Identifiers

Package DI Number

35019517078798

Quantity per Package

10

Contains DI Package

15019517078794

Package Discontinue Date

-

Package Status

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 14
2 A medical device with a moderate to high risk that requires special controls. 9371