Catalog Number

-

Brand Name

S100 Handheld quick connect

Version/Model Number

70-0287

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

-

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

K153084,K153084

Product Code

NHV

Product Code Name

System, Water Purification, General Medical Use

Public Device Record Key

c1a9b028-45a6-4f2d-b5d2-1e3108877652

Public Version Date

September 17, 2021

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

10896241002586

Quantity per Package

6

Contains DI Package

00896241002589

Package Discontinue Date

September 16, 2021

Package Status

Not in Commercial Distribution

Package Type

carton