Assure® Platinum Blood Glucose Meter - Assure Platinum Meter Institutional multi-pack (4 - ARKRAY USA, INC.

Duns Number:008171162

Device Description: Assure Platinum Meter Institutional multi-pack (4 Assure Platinum meter kits PN 500001)

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More Product Details

Catalog Number

-

Brand Name

Assure® Platinum Blood Glucose Meter

Version/Model Number

501177

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

K092104

Product Code Details

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Device Record Status

Public Device Record Key

55160898-02eb-46b7-81df-8cd9b475aa7b

Public Version Date

June 27, 2022

Public Version Number

1

DI Record Publish Date

June 17, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARKRAY USA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 30
2 A medical device with a moderate to high risk that requires special controls. 50