Heart and Respiration Rate Monitoring System powered by EarlySense

GUDID 00887761985155

EarlySense Sensor Assembly

HILL-ROM, INC.

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• Primary Device ID: 00887761985155
• NIH Device Record Key: 9db609e7-8d83-4656-a8f1-cd6f24217a51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heart and Respiration Rate Monitoring System powered by EarlySense
• Version Model Number: P200898
• Company DUNS: 004245668
• Company Name: HILL-ROM, 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: 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: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887761975729 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	00887761985155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180079

FDA Product Code

• BZQ: Monitor, breathing frequency

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: 2018-11-29
• Device Publish Date: 2018-08-22

On-Brand Devices [Heart and Respiration Rate Monitoring System powered by EarlySense]

• 00887761985155: EarlySense Sensor Assembly
• 00887761975705: EarlySense Sensor Assembly