EPS 10 C 24 Medical Device Identification

GUDID 03700712420338

EPS 10 C 24

MAQUET SAS

Operating room light

Primary Device ID	03700712420338
NIH Device Record Key	67c1f9ea-bf53-4bd1-9967-d005d230076c
Commercial Distribution Status	In Commercial Distribution
Version Model Number	ARD567355911
Company DUNS	264700139
Company Name	MAQUET SAS
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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 Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
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 Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
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 Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
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 Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
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 Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
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 Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
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 Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
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 Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
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 Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
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 Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
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 Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
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 Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
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 Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
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 Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
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 Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
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	03700712420338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K130513

FDA Product Code

FTA	Light, Surgical, Accessories

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	2022-04-05
Device Publish Date	2022-03-28

Devices Manufactured by MAQUET SAS

03700712434540 - Volista	2025-06-13 VCSII60SF SAX12
03700712434557 - Volista	2025-06-13 VCSII60DF SAX08
03700712434564 - Volista	2025-06-13 VCSII66SF SAX1012
03700712434571 - Volista	2025-06-13 VCSII66DF SAX0810
03700712434588 - Volista	2025-06-13 VCSII40SF SAX12
03700712434595 - Volista	2025-06-13 VCSII40DF SAX08
03700712434601 - Volista	2025-06-13 VCSII44SF SAX1012
03700712434618 - Volista	2025-06-13 VCSII44DF SAX0810