Enbio-Autoclave Control Firmware

GUDID 07629999978836

Firmware dedicated only to the Enbio S autoclave and created by our company. This firmware does not give the possibility to the end user of any interference in the device operating parameters and records of carried out sterilization or tests.

Enbio Group AG

Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer
Primary Device ID07629999978836
NIH Device Record Key16ca9ccd-2465-4f9d-95b4-8c8fc01aadfc
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnbio-Autoclave Control Firmware
Version Model Number35
Company DUNS480232605
Company NameEnbio Group AG
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+18786701641
Emaililona.ralston@enbio.com
Phone+18786701641
Emaililona.ralston@enbio.com
Phone+18786701641
Emaililona.ralston@enbio.com
Phone+18786701641
Emaililona.ralston@enbio.com
Phone+18786701641
Emaililona.ralston@enbio.com
Phone+18786701641
Emaililona.ralston@enbio.com
Phone+18786701641
Emaililona.ralston@enbio.com
Phone+18786701641
Emaililona.ralston@enbio.com
Phone+18786701641
Emaililona.ralston@enbio.com
Phone+18786701641
Emaililona.ralston@enbio.com
Phone+18786701641
Emaililona.ralston@enbio.com
Phone+18786701641
Emaililona.ralston@enbio.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107629999978836 [Primary]

FDA Product Code

FLESterilizer, Steam

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-09
Device Publish Date2022-03-01

Devices Manufactured by Enbio Group AG

07629999190788 - Enbio2024-04-02 The Enbio S is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize me
07629999413511 - Enbio2022-03-09 The Enbio S is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize
07629999504721 - Enbio Data Viewer2022-03-09 Software dedicated only to the Enbio autoclaves and created by our company. It will be a read-only, visualization software for c
07629999978836 - Enbio-Autoclave Control Firmware2022-03-09Firmware dedicated only to the Enbio S autoclave and created by our company. This firmware does not give the possibility to the end user of any interference in the device operating parameters and records of carried out sterilization or tests.
07629999978836 - Enbio-Autoclave Control Firmware2022-03-09 Firmware dedicated only to the Enbio S autoclave and created by our company. This firmware does not give the possibility to the

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