Maquet Equipment

GUDID 03700712420147

EQTXHS021 08

MAQUET SAS

Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount

Primary Device ID	03700712420147
NIH Device Record Key	18a97c54-d83b-47f4-9206-80a5280e2ad7
Commercial Distribution Status	In Commercial Distribution
Brand Name	Maquet Equipment
Version Model Number	ARDEQT239025A
Company DUNS	264700139
Company Name	MAQUET SAS
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Operating and Storage Conditions

Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700712420147 [Primary]

FDA Product Code

FXR	Holder, Camera, Surgical

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-04-04
Device Publish Date	2022-03-25

On-Brand Devices [Maquet Equipment ]

03700712420147	EQTXHS021 08
03700712420130	EQTXHS010 08
03700712417277	EQTXHD127 16
03700712417260	EQTXHD127 11
03700712417253	EQTXHD127 08
03700712417246	EQTXHD127 SAT13
03700712417239	EQTXHD127 SAT12
03700712417161	EQTMHS013 16
03700712417154	EQTMHS013 14
03700712417147	EQTMHS021 16
03700712417130	EQTMHS021 14
03700712417123	EQTMHD231 16
03700712417024	EQTXHS021 16
03700712417017	EQTXHS021 14
03700712417000	EQTXHS010 16
03700712416997	EQTXHS010 14
03700712416829	EQTSC07 SAT16
03700712416126	EQTXHS010 SAT12
03700712416119	EQTXHS010 SAT13
03700712416102	EQTXHS021 SAT13
03700712416096	EQTXHS021 SAT12
03700712416072	EQTXHS010 11
03700712416065	EQTXHS021 11
03700712415778	EQTMHD231 11
03700712414184	EQTFHS010 11
03700712414177	EQTMHS013 11
03700712414160	EQTMHS021 11
03700712411923	EQTMHD2 31 SAT13
03700712411916	EQTMHD2 31 SAT12
03700712411909	EQTMHS0 21 SAT13
03700712411893	EQTMHS0 21 SAT12
03700712411886	EQTMHS0 13 SAT13
03700712411879	EQTMHS0 13 SAT12
03700712411862	EQTFHS0 10 SAT13
03700712411855	EQTFHS0 10 SAT12
03700712422592	EQTSPC12 SATX13
03700712422585	EQTSPC12 SATX15
03700712422554	EQTXHD127 SATX13
03700712422547	EQTXHD127 SATX15
03700712422530	EQTXHS021 SATX13
03700712422523	EQTXHS021 SATX15
03700712422516	EQTXHS016 SATX13
03700712422509	EQTMHD237 SATX15
03700712422493	EQTMHS035 SATX13
03700712422486	EQTMHS035 SATX15
03700712422479	EQTMHS019 SATX15
03700712422448	EQTSC05 SATX15
03700712422431	EQTXO SATX13
03700712422424	EQTSPC12 SAX12
03700712422417	EQTXO SAX16