Catalog Number

IN900012

Brand Name

N/A

Version/Model Number

IN900012

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 27, 2021

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

c9b86276-7185-4798-85b3-a463b32b842e

Public Version Date

January 27, 2021

Public Version Number

2

DI Record Publish Date

December 28, 2020

Package DI Number

57613327500115

Quantity per Package

12

Contains DI Package

07613327500110

Package Discontinue Date

January 27, 2021

Package Status

Not in Commercial Distribution

Package Type

case