SleepmatePiezo Crystal Sensor & Band, Adult/Ped, D 813246-100

GUDID 05707480041381

Ref. 1312 (Adult/ped)-Double Loop

Ambu A/S

Polysomnograph

• Primary Device ID: 05707480041381
• NIH Device Record Key: 319395bc-f143-49e5-9c07-397ceabcc743
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SleepmatePiezo Crystal Sensor & Band, Adult/Ped, D
• Version Model Number: 813246-100
• Catalog Number: 813246-100
• 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	05707480041381 [Primary]
GS1	05707480101245 [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: 4
• Public Version Date: 2018-10-29
• Device Publish Date: 2016-09-21

On-Brand Devices [SleepmatePiezo Crystal Sensor & Band, Adult/Ped, D]

• 05707480041381: Ref. 1312 (Adult/ped)-Double Loop
• 05707480041343: Piezo Crystal Sensor & Band (adult/ped) Double Buckle (Sleepmate item 1310) Min. purchase is 5 p