MR Patient Care Kit, Sample, Agents, 3160 94018

GUDID 00884838120563

KIT,SAMPLE,AGENTS,3160

Philips Medizin Systeme Böblingen GmbH

Exhaled-gas sample collector, non-electronic

• Primary Device ID: 00884838120563
• NIH Device Record Key: 7127daa5-5d80-4e2f-8017-9e62842ffd13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR Patient Care Kit, Sample, Agents, 3160
• Version Model Number: Kit, Sample, Agents, 3160
• Catalog Number: 94018
• Company DUNS: 314101143
• Company Name: Philips Medizin Systeme Böblingen GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 427 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 427 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 427 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 427 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 427 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 427 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 427 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 427 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 427 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 427 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 427 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 427 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 427 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 427 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 427 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838120563 [Primary]

FDA Product Code

• MWI: Monitor, Physiological, Patient (Without 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: 2025-05-29
• Device Publish Date: 2025-05-21

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• 00884838126411 - Leads: 2025-07-24 Wireless PIM Leadwires for PageWriter TC Series Cardiographs, 10-lead, AAMI color-coding, 3mm needle
• 00884838126428 - Leads: 2025-07-24 Wireless PIM Leadwires for PageWriter TC Series Cardiographs,10-lead, IEC color-coding, 4mm banana
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• 00884838114951 - NIBP Cuffs: 2025-07-11 Neonatal Soft Single-Patient Cuff Size#2
• 00884838114975 - NIBP Cuffs: 2025-07-11 Neonatal Soft Single-Patient Cuff Size#2
• 00884838114999 - NIBP Cuffs: 2025-07-11 Neonatal Soft Single-Patient Cuff Size#2