VitalSense 500-0100-02

GUDID 00606959021648

Finished Good, VitalSense Temperature Capsule

Respironics, Inc.

Temperature telemetric monitoring system transmitter

• Primary Device ID: 00606959021648
• NIH Device Record Key: b9df3132-cc35-4f36-ac74-ee5ad91f93a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitalSense
• Version Model Number: VITALSENSE
• Catalog Number: 500-0100-02
• Company DUNS: 080728314
• Company Name: Respironics, Inc.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959021648 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033534

FDA Product Code

• FLL: Thermometer, electronic, clinical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-28

On-Brand Devices [VitalSense]

• 00606959021648: Finished Good, VitalSense Temperature Capsule
• 00606959033337: Finished Good, VitalSense, Temperature Dermal Patch