GranuFlo 0FD3301-3B

GUDID 00840861101603

GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis

Fresenius Medical Care Renal Therapies Group, LLC

Haemodialysis concentrate

• Primary Device ID: 00840861101603
• NIH Device Record Key: 123ee142-5835-487c-9b73-81151dcd642e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GranuFlo
• Version Model Number: 0FD3301-3B
• Catalog Number: 0FD3301-3B
• Company DUNS: 079732391
• Company Name: Fresenius Medical Care Renal Therapies Group, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
• Special Storage Condition, Specify: Between 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861101603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030497

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-02

On-Brand Devices [GranuFlo]

• 00840861101603: GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis
• 00840861101597: GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis
• 00840861101580: GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis
• 00840861101573: GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis
• 00840861101542: GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis
• 00840861101535: GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis
• 00840861101528: GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis
• 00840861101481: GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis
• 00840861101474: GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis