Catalog Number

TM0009

Brand Name

BioTel Care BGM 4

Version/Model Number

TM0009

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

K110571,K110571

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

fb122ebf-a99b-4a94-a528-e12a4081195a

Public Version Date

January 25, 2021

Public Version Number

1

DI Record Publish Date

January 16, 2021

Package DI Number

00859519002391

Quantity per Package

1

Contains DI Package

00859519002407

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-