DK50 DS - EKOM spol. s r.o.

Duns Number:360551766

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More Product Details

Catalog Number

-

Brand Name

DK50 DS

Version/Model Number

STA NOZ 230V/60Hz 3bar NO

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K091871

Product Code Details

Product Code

BTI

Product Code Name

Compressor, Air, Portable

Device Record Status

Public Device Record Key

b5b2815a-2385-44c8-9100-624fab5c0730

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EKOM SPOL. S R.O." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 91