SAVe II+

GUDID 90851629008075

SAVe II+ US Kit with Mask & Headstrap

Automedx, LLC

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• Primary Device ID: 90851629008075
• NIH Device Record Key: 2b91593a-a8e6-43b7-b5d0-291d775cdb75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAVe II+
• Version Model Number: 70111H-US
• Company DUNS: 606696123
• Company Name: Automedx, LLC
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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: 18554286074
• Email: INFO@safeguardmedical.com
• Phone: 18554286074
• Email: INFO@safeguardmedical.com
• Phone: 18554286074
• Email: INFO@safeguardmedical.com
• Phone: 18554286074
• Email: INFO@safeguardmedical.com
• Phone: 18554286074
• Email: INFO@safeguardmedical.com
• Phone: 18554286074
• Email: INFO@safeguardmedical.com
• Phone: 18554286074
• Email: INFO@safeguardmedical.com
• Phone: 18554286074
• Email: INFO@safeguardmedical.com
• Phone: 18554286074
• Email: INFO@safeguardmedical.com
• Phone: 18554286074
• Email: INFO@safeguardmedical.com
• Phone: 18554286074
• Email: INFO@safeguardmedical.com
• Phone: 18554286074
• Email: INFO@safeguardmedical.com
• Phone: 18554286074
• Email: INFO@safeguardmedical.com
• Phone: 18554286074
• Email: INFO@safeguardmedical.com
• Phone: 18554286074
• Email: INFO@safeguardmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	90851629008075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131877

FDA Product Code

• BTL: Ventilator, Emergency, Powered (Resuscitator)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-15
• Device Publish Date: 2024-01-06

On-Brand Devices [SAVe II+]

• 90851629008075: SAVe II+ US Kit with Mask & Headstrap
• 20851629008076: SAVe II+ Kit, A&C plugs
• 10851629008079: SAVe II+ Kit, US Plug
• 00851629008072: SAVe II+ Ventilator