Actril Residual Test Strips - MEDIVATORS INC.

Duns Number:068199363

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More Product Details

Catalog Number

-

Brand Name

Actril Residual Test Strips

Version/Model Number

78258-000

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K861730,K861730

Product Code Details

Product Code

FKQ

Product Code Name

System, Dialysate Delivery, Central Multiple Patient

Device Record Status

Public Device Record Key

0dc5ff56-d073-4b55-98fd-6a6869e28663

Public Version Date

April 27, 2022

Public Version Number

5

DI Record Publish Date

July 09, 2018

Additional Identifiers

Package DI Number

30677964008253

Quantity per Package

100

Contains DI Package

40677964023987

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDIVATORS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2999
2 A medical device with a moderate to high risk that requires special controls. 362