Outset Liquid Bicarbonate Concentrate

GUDID 30677964068196

MEDIVATORS INC.

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• Primary Device ID: 30677964068196
• NIH Device Record Key: 9b79b41c-69e0-4938-b8e5-793ddaa5dc91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Outset Liquid Bicarbonate Concentrate
• Version Model Number: B-100
• Company DUNS: 068199363
• Company Name: MEDIVATORS INC.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00677964068195 [Primary]
GS1	30677964068196 [Package]; Contains: 00677964068195; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K843963

FDA Product Code

• FKQ: System, Dialysate Delivery, Central Multiple Patient

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: 2018-03-29
• Device Publish Date: 2016-09-20

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