KetoSens - KetoSens B-Ketone Monitoring System with Lancets - i-SENS, Inc.

Duns Number:688840958

Device Description: KetoSens B-Ketone Monitoring System with Lancets

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More Product Details

Catalog Number

-

Brand Name

KetoSens

Version/Model Number

276261-201

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K170463,K170463

Product Code Details

Product Code

JIN

Product Code Name

Nitroprusside, Ketones (Urinary, Non-Quant.)

Device Record Status

Public Device Record Key

b5ce0c86-49b9-42d5-baef-82082b3de81f

Public Version Date

November 18, 2020

Public Version Number

1

DI Record Publish Date

November 10, 2020

Additional Identifiers

Package DI Number

10885325000853

Quantity per Package

70

Contains DI Package

00885325000856

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case Carton

"I-SENS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 20