Outset Acid Concentrate

GUDID 30677964068172

MEDIVATORS INC.

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• Primary Device ID: 30677964068172
• NIH Device Record Key: 3c1a1612-1cf4-4a19-9523-45e9c5eb4f6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Outset Acid Concentrate
• Version Model Number: A-225
• 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: false
• 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	00677964068171 [Primary]
GS1	30677964068172 [Package]; Contains: 00677964068171; 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

On-Brand Devices [Outset Acid Concentrate]

• 30677964068189: A-325
• 30677964068172: A-225