BiDop 7 probe - 10 mhz curly cable Probe for Bidop 7 - KOVEN TECHNOLOGY, INC.

Duns Number:069261402

Device Description: 10 mhz curly cable Probe for Bidop 7

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More Product Details

Catalog Number

ST10M5S8C

Brand Name

BiDop 7 probe

Version/Model Number

ST10M5S8C

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

K201114

Product Code Details

Product Code

DPW

Product Code Name

Flowmeter, Blood, Cardiovascular

Device Record Status

Public Device Record Key

061a3f29-0096-4448-aa8e-62bed775bb8f

Public Version Date

January 28, 2021

Public Version Number

1

DI Record Publish Date

January 20, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KOVEN TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 86