Mobile Keyboard Dock - Mobile Keyboard Dock with backpack - Bk Medical ApS

Duns Number:310093901

Device Description: Mobile Keyboard Dock with backpack

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More Product Details

Catalog Number

-

Brand Name

Mobile Keyboard Dock

Version/Model Number

UA1210

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

K081154

Product Code Details

Product Code

IYN

Product Code Name

System, Imaging, Pulsed Doppler, Ultrasonic

Device Record Status

Public Device Record Key

03be8204-046a-48df-90aa-827b6fc2877b

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BK MEDICAL APS" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 92