ARGUS PB-3000 3.921031

GUDID 07613365003475

The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical System (Host System) for acquiring, analysing, and transmission of patient vitals and other pertinent clinical data.

Schiller AG

Patient monitoring system module, multifunction

Primary Device ID	07613365003475
NIH Device Record Key	c9ab9add-360a-49ba-a8cf-91e611b607b8
Commercial Distribution Status	In Commercial Distribution
Brand Name	ARGUS PB-3000
Version Model Number	PB-3000 Var.9, sub-variant: Q
Catalog Number	3.921031
Company DUNS	480868538
Company Name	Schiller AG
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	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+41417664242
Email	info@schiller.ch
Phone	+41417664242
Email	info@schiller.ch
Phone	+41417664242
Email	info@schiller.ch
Phone	+41417664242
Email	info@schiller.ch
Phone	+41417664242
Email	info@schiller.ch
Phone	+41417664242
Email	info@schiller.ch
Phone	+41417664242
Email	info@schiller.ch
Phone	+41417664242
Email	info@schiller.ch
Phone	+41417664242
Email	info@schiller.ch
Phone	+41417664242
Email	info@schiller.ch
Phone	+41417664242
Email	info@schiller.ch
Phone	+41417664242
Email	info@schiller.ch
Phone	+41417664242
Email	info@schiller.ch
Phone	+41417664242
Email	info@schiller.ch
Phone	+41417664242
Email	info@schiller.ch
Phone	+41417664242
Email	info@schiller.ch
Phone	+41417664242
Email	info@schiller.ch

Operating and Storage Conditions

Handling Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613365003475 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K221056

FDA Product Code

MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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	2023-09-12
Device Publish Date	2023-09-04

On-Brand Devices [ARGUS PB-3000]

07613365002782	The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a
07613365002713	The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a
07613365003475	The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a
07613365003468	The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a
07613365003024	The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a
07613365002829	The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a
07613365002812	The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a
07613365002805	The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a
07613365002799	The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a
07613365002706	The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a
07613365002584	The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a
07613365001914	The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a
07613365001846	The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a
07613365001709	The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a
07613365000115	The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a