Catalog Number

-

Brand Name

CareSens N Plus BT

Version/Model Number

164372

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K171480,K171480

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

ad9e7175-bcee-4520-8dba-48be7cc2ee83

Public Version Date

November 19, 2020

Public Version Number

1

DI Record Publish Date

November 11, 2020

Package DI Number

10885325001379

Quantity per Package

50

Contains DI Package

00885325001372

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case Carton