Catalog Number

PIB1000

Brand Name

N/A

Version/Model Number

PIB1000

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

KZD

Product Code Name

INFUSOR, PRESSURE, FOR I.V. BAGS

Public Device Record Key

7e6d584e-072f-411f-8304-8fc3ec9c34ff

Public Version Date

April 28, 2022

Public Version Number

3

DI Record Publish Date

October 21, 2019

Package DI Number

57613327500108

Quantity per Package

12

Contains DI Package

07613327500103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case