Catalog Number

-

Brand Name

H2H Infusion Set

Version/Model Number

70-5828

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 16, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K112314,K112314

Product Code

FIP

Product Code Name

Subsystem, Water Purification

Public Device Record Key

76266417-409a-4b52-bccc-047bb9c868a1

Public Version Date

September 17, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

10896241002067

Quantity per Package

25

Contains DI Package

00896241002060

Package Discontinue Date

September 16, 2021

Package Status

Not in Commercial Distribution

Package Type

Carton