DK50 DS - EKOM spol. s r.o.

Duns Number:360551766

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More Product Details

Catalog Number

430402009-113

Brand Name

DK50 DS

Version/Model Number

230V/50Hz 3bar NO STA NOZ

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

-

Product Code Details

Product Code

BTI

Product Code Name

Compressor, Air, Portable

Device Record Status

Public Device Record Key

ee8aa868-4ccf-4eb1-86e7-e2515c2f9215

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 16, 2018

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