SleepmatePiezo Crystal Sensor & Band, Adult/Ped, Double Buckle, Alice 813206-121

GUDID 05707480041411

Alice 5 Piezo Crystal Sensor

Ambu A/S

Polysomnograph

• Primary Device ID: 05707480041411
• NIH Device Record Key: 7f7a35f1-f870-4ab9-b525-b18e42be99c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SleepmatePiezo Crystal Sensor & Band, Adult/Ped, Double Buckle, Alice
• Version Model Number: 813206-121
• Catalog Number: 813206-121
• Company DUNS: 305682023
• Company Name: Ambu A/S
• Device Count: 1
• DM Exempt: false
• 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: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480041411 [Primary]
GS1	05707480101290 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K903300

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: 5
• Public Version Date: 2019-10-30
• Device Publish Date: 2016-09-21

On-Brand Devices [SleepmatePiezo Crystal Sensor & Band, Adult/Ped, Double Buckle, Alice ]

• 05707480041411: Alice 5 Piezo Crystal Sensor
• 05707480041398: Alice 3 Piezo Crystal Sensor