Catalog Number

-

Brand Name

Single lead High Volume Pump Chamber Set

Version/Model Number

G82711-M

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"

-

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

K850757,K850757

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

109d012c-69bc-4894-a473-c3bfe5f5f429

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

February 22, 2017

Package DI Number

10816513022647

Quantity per Package

10

Contains DI Package

00816513022640

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX