E1

GUDID 08586014620066

EKOM spol. s r.o.

Medical device air compressor
Primary Device ID08586014620066
NIH Device Record Key306b6aa2-3039-4f4c-bec0-3a4e408c835b
Commercial Distribution Discontinuation2018-09-26
Commercial Distribution StatusNot in Commercial Distribution
Brand NameE1
Version Model Number110-120V/60-50Hz
Company DUNS360551766
Company NameEKOM spol. s r.o.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS108586014620066 [Primary]

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 Number3
Public Version Date2023-07-28
Device Publish Date2016-05-13

On-Brand Devices [E1]

08586014620073220-240V/50-60Hz
08586014620066110-120V/60-50Hz
0858601462005990-100V/50-60 Hz

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