CNAP® double finger cuff "medium" - Unit, with Infinity Lifecycle (1000h) - CNSystems Medizintechnik GmbH

Duns Number:300526077

Device Description: Unit, with Infinity Lifecycle (1000h)

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More Product Details

Catalog Number

20-FVMA-15520I

Brand Name

CNAP® double finger cuff "medium"

Version/Model Number

V4.4

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K082599

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

6287f1b5-6ace-402f-9065-b9f662412170

Public Version Date

December 31, 2018

Public Version Number

1

DI Record Publish Date

November 28, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CNSYSTEMS MEDIZINTECHNIK GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 60