Catalog Number

-

Brand Name

PulseSpray

Version/Model Number

12500463

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)

Yes

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

K163356,K951509

Product Code

KRA

Product Code Name

Catheter, continuous flush

Public Device Record Key

21c1f6b5-4f1a-4b43-8089-dd7ffcd70c0f

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

September 19, 2016

Package DI Number

H787125004635

Quantity per Package

1

Contains DI Package

H787125004630

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX