Catalog Number

-

Brand Name

n.a.

Version/Model Number

58-08-050

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

-

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

bc20540f-9de0-4a84-bd4b-ad80f1199e0a

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

September 02, 2020

Package DI Number

24250105627668

Quantity per Package

1

Contains DI Package

14250105627661

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-