Multikuf™ - Pediatric Multicuff Kit,Multicuff, 1 pc Cuffs - AMERICAN DIAGNOSTIC CORP

Duns Number:108999095

Device Description: Pediatric Multicuff Kit,Multicuff, 1 pc Cuffs

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More Product Details

Catalog Number

705PMK-MCC1

Brand Name

Multikuf™

Version/Model Number

705PMK-MCC1

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"

Yes

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

-

Product Code Details

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Device Record Status

Public Device Record Key

ad2aac82-c073-4b61-b0ec-e29e70c18bb2

Public Version Date

September 07, 2020

Public Version Number

1

DI Record Publish Date

August 29, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMERICAN DIAGNOSTIC CORP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2395
2 A medical device with a moderate to high risk that requires special controls. 1769