Catalog Number

-

Brand Name

TIGER MEDICAL PRESSURE INFUSERS

Version/Model Number

IAT101

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

5a1cd310-53e9-49f3-b261-a16a0c6f46ee

Public Version Date

July 25, 2022

Public Version Number

1

DI Record Publish Date

July 15, 2022

Package DI Number

10840216100418

Quantity per Package

5

Contains DI Package

00840216100411

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack