SleepmateDisposable AirFlow Sensor, Small / Infant 814301-000/20

GUDID 05707480042364

Sensors, Small/Infant. Pack of 20 pcs. (Sleepmate item 1428)

Ambu A/S

Polysomnograph

• Primary Device ID: 05707480042364
• NIH Device Record Key: d3c25a93-090f-400a-8baf-87486ac7f7e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SleepmateDisposable AirFlow Sensor, Small / Infant
• Version Model Number: 814301-000/20
• Catalog Number: 814301-000/20
• Company DUNS: 305682023
• Company Name: Ambu A/S
• Device Count: 20
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480042364 [Primary]
GS1	05707480133949 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922112

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: 2018-07-06
• Device Publish Date: 2016-09-21

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• 05707480006403 - Perfit Collar™: 2026-01-30 Collar Perfit Pediatric size 2
• 05707480006410 - Perfit Collar™: 2026-01-30 Collar Perfit Neckless, size 3
• 05707480006427 - Perfit Collar™: 2026-01-30 Collar Perfit short size 4
• 05707480006434 - Perfit Collar™: 2026-01-30 Collar Perfit regular, size 5
• 05707480006441 - Perfit Collar™: 2026-01-30 Collar Perfit tall size 6
• 05707480006458 - Perfit Collar™: 2026-01-30 Collar Perfit Regular size 1
• 05707480006465 - Perfit Collar™: 2026-01-30 Collar Perfit Pediatric, size 2, cases of 50 PCS