Vented Luer Tip Cap - Vented Luer Tip Cap - WESTMED, INC.

Duns Number:092673953

Device Description: Vented Luer Tip Cap

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More Product Details

Catalog Number

-

Brand Name

Vented Luer Tip Cap

Version/Model Number

0405

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2022

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

K945454,K945454

Product Code Details

Product Code

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Device Record Status

Public Device Record Key

b4a250c7-bbca-4f5c-9cf2-e4c851182eaf

Public Version Date

September 30, 2022

Public Version Number

3

DI Record Publish Date

May 15, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WESTMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 746
2 A medical device with a moderate to high risk that requires special controls. 320