Catalog Number

2S0706

Brand Name

Aquastat SFR

Version/Model Number

2S0706

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"

Yes

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

K120836,K120836,K120836

Product Code

NGT

Product Code Name

Saline, Vascular Access Flush

Public Device Record Key

3ca769f3-e87e-487e-8d04-efba7c047969

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

20859809005006

Quantity per Package

4

Contains DI Package

10859809005009

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case