Catalog Number

5920-012-000

Brand Name

SmartPump

Version/Model Number

5920012000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2019

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

-

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

KCY

Product Code Name

TOURNIQUET, PNEUMATIC

Public Device Record Key

f4a96b8d-262a-46b4-808e-e6e3ef6a7251

Public Version Date

May 10, 2021

Public Version Number

4

DI Record Publish Date

September 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-