SleepmateRIPmate Kit with Disposable Bands - STD 819200-100

GUDID 05707480107186

RIPmate Kit with Disposable Bands - STD

Ambu A/S

Polysomnograph

• Primary Device ID: 05707480107186
• NIH Device Record Key: e4a92b94-3b6c-47f6-b713-2969d20aacb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SleepmateRIPmate Kit with Disposable Bands - STD
• Version Model Number: 819200-100
• Catalog Number: 819200-100
• 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	05707480096879 [Direct Marking]
GS1	05707480107186 [Primary]

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

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