Catalog Number

515085

Brand Name

BD PhaSeal™ Optima Infusion Clamp M25-O

Version/Model Number

515085

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

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

KMK

Product Code Name

DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Public Device Record Key

f1cd279d-8f34-45f7-b38f-31aaca97f4b5

Public Version Date

July 08, 2020

Public Version Number

1

DI Record Publish Date

June 30, 2020

Package DI Number

30382905150853

Quantity per Package

25

Contains DI Package

00382905150852

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfpack