Sleepmate / SparepartBody Position Band 815000-000

GUDID 05707480042548

Body Position Band

Ambu A/S

Polysomnograph

• Primary Device ID: 05707480042548
• NIH Device Record Key: 112611b8-38bb-4fc7-9b02-a8b0628bcb7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sleepmate / SparepartBody Position Band
• Version Model Number: 815000-000
• Catalog Number: 815000-000
• 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: false
• 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	05707480042548 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923033

FDA Product Code

• LXJ: System, optical position/movement recording

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-04
• Device Publish Date: 2019-01-10

Devices Manufactured by Ambu A/S

• 05707480161867 - Ambu® aScope™ Gastro Large: 2024-04-25 Gastroscope
• 05707480021697 - Disposable Face Masks: 2024-04-16 Ambu disposable face mask, size neonate
• 05707480021703 - Disposable Face Masks: 2024-04-16 Face mask
• 05707480021710 - Disposable Face Masks: 2024-04-16 Ambu disposable face mask, size toddler, with hook ring,
• 05707480005635 - Disposable Face Masks: 2024-04-16 Ambu disposable face mask, size small adult/child, with hook ring
• 05707480021734 - Disposable Face Masks: 2024-04-16 Ambu disposable face mask, size medium adult, with hook ring
• 05707480021741 - Disposable Face Masks: 2024-04-16 Ambu disposable face mask, size large adult, with hook ring
• 05707480150441 - Ambu® SPUR® II Pediatric Resuscitator: 2024-03-07 w/CO2 Detector