Dry Acid Dissolution Unit

GUDID 00840861100996

132 Gallon

Fresenius Usa, Inc.

Haemodialysis system fluid mixer

• Primary Device ID: 00840861100996
• NIH Device Record Key: 1eb95446-0553-4bb1-bd10-50554625ec84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dry Acid Dissolution Unit
• Version Model Number: 160147
• Company DUNS: 076594100
• Company Name: Fresenius Usa, 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: false
• Serial Number: true
• Manufacturing Date: false
• 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: +1(800)323-5188
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861100996 [Primary]

FDA Product Code

• KPO: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

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: 2015-10-02

On-Brand Devices [Dry Acid Dissolution Unit]

• 00840861101009: 99 Gallon
• 00840861100996: 132 Gallon