SleepmateRIPmate A5 Abdomen Processor 819180-000

GUDID 05707480041213

RIPmate A5 Abdomen Processor

Ambu A/S

Polysomnograph

• Primary Device ID: 05707480041213
• NIH Device Record Key: 56ee129f-80f2-4b4e-a1d5-b24ea3b3a495
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SleepmateRIPmate A5 Abdomen Processor
• Version Model Number: 819180-000
• Catalog Number: 819180-000
• 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: 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	05707480041213 [Primary]
GS1	05707480096916 [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

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