NaturaLyte 08-1231-3

GUDID 10840861101648

NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case

Fresenius Medical Care Renal Therapies Group, LLC

Haemodialysis concentrate

• Primary Device ID: 10840861101648
• NIH Device Record Key: 441dae28-f0a7-4b00-b507-e39d8e94b7b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NaturaLyte
• Version Model Number: 08-1231-3
• Catalog Number: 08-1231-3
• 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
• 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 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed when not in use.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861101641 [Primary]
GS1	10840861101648 [Package]; Contains: 00840861101641; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192017
• Premarket Notification: K981043

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 [NaturaLyte]

• 00840861101887: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Drum
• 00840861101870: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Drum
• 00840861101863: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Drum
• 00840861101856: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Drum
• 00840861101849: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Drum
• 00840861101832: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Drum
• 10840861101808: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case
• 10840861101754: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case
• 10840861101747: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case
• 10840861101730: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case
• 10840861101723: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case
• 10840861101716: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case
• 10840861101709: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case
• 10840861101693: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case
• 10840861101686: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case
• 10840861101679: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case
• 10840861101662: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case
• 10840861101655: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case
• 10840861101648: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case
• 10840861101631: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case
• 10840861101624: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case
• 10840861101617: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case