Catalog Number

-

Brand Name

HCS

Version/Model Number

HCS9201-3000

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

KZD

Product Code Name

Infusor, Pressure, For I.V. Bags

Public Device Record Key

19b741b7-0654-42bf-894e-bd1787b067ad

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

May 29, 2020

Package DI Number

10849027004649

Quantity per Package

25

Contains DI Package

00849027004642

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case