DK50 DS

GUDID 08586014621407

EKOM spol. s r.o.

Medical device air compressor
Primary Device ID08586014621407
NIH Device Record Keya5c1b143-384b-4d26-823f-e3114dff8e6f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDK50 DS
Version Model Number120V/60Hz UL 3bar NO
Company DUNS360551766
Company NameEKOM spol. s r.o.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108586014621407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTICompressor, Air, Portable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-20
Device Publish Date2022-10-12

On-Brand Devices [DK50 DS]

08586014621407120V/60Hz UL 3bar NO
08586014625047BAS NOZ 115V 60Hz 3bar NO MEK

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