Medistim Interconnect cable - Medistim ASA

Duns Number:519521751

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More Product Details

Catalog Number

CD204011

Brand Name

Medistim Interconnect cable

Version/Model Number

CD204011

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

K040228

Product Code Details

Product Code

DPW

Product Code Name

Flowmeter, Blood, Cardiovascular

Device Record Status

Public Device Record Key

3616017e-4aa2-406b-a60c-0d1401df16e8

Public Version Date

November 09, 2020

Public Version Number

1

DI Record Publish Date

October 30, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDISTIM ASA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 129