VPS 1 Medical Device Identification

GUDID 03700712400910

VPS 1

MAQUET SAS

Operating room light

Primary Device ID	03700712400910
NIH Device Record Key	1e1449ba-27fc-4a2e-a5f7-648f50d82099
Commercial Distribution Status	In Commercial Distribution
Version Model Number	ARD568407901
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
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	03700712400910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K130513

FDA Product Code

FTA	Light, Surgical, Accessories
FTD	Lamp, surgical

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2021-01-08
Device Publish Date	2016-09-12

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03700712415693 - Volista	2025-01-14 VST64DF VP TK AIM 0810
03700712432713 - Volista	2025-01-13 VCSII64SFDF SB1011
03700712433055 - Volista	2025-01-13 VSTII40DF FHS019 SAX1012
03700712433062 - Volista	2025-01-13 VSTII40DF MHS019 SAX1012