Catalog Number

-

Brand Name

CAP SYSTEM (10 NOZZLE)

Version/Model Number

PF-N100-10

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KYX

Product Code Name

Dispenser, Liquid Medication

Public Device Record Key

da9ecf41-11d7-494f-a5d6-21b164052dbd

Public Version Date

September 01, 2022

Public Version Number

1

DI Record Publish Date

August 24, 2022

Package DI Number

10810080611709

Quantity per Package

2

Contains DI Package

00810080611702

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case