MC40 C

GUDID 08586014620301

EKOM spol. s r.o.

Medical device air compressor
Primary Device ID08586014620301
NIH Device Record Key40edffdf-6d28-427a-8d07-e69b8f943b56
Commercial Distribution Discontinuation2018-09-26
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMC40 C
Version Model Number230V/50Hz KAR
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
GS108586014620301 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-07-28
Device Publish Date2016-05-26

Devices Manufactured by EKOM spol. s r.o.

08586014620059 - E12023-07-28
08586014620066 - E12023-07-28
08586014620073 - E12023-07-28
08586014620301 - MC40 C 2023-07-28
08586014620301 - MC40 C 2023-07-28
08586014625047 - DK50 DS2023-06-22
08586014620295 - MC40 2023-06-12
08586014620905 - DK50 DM2023-06-12
08586014620912 - DK50 D2023-06-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.