NaturaLyte 08-4400-1

GUDID 10840861101969

NaturaLyte Dry Pack Sodium Bicarbonate, Carton

Fresenius Medical Care Holdings, Inc.

Haemodialysis concentrate

• Primary Device ID: 10840861101969
• NIH Device Record Key: 98450890-0b14-486a-9807-0b91a479eb3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NaturaLyte
• Version Model Number: 08-4400-1
• Catalog Number: 08-4400-1
• Company DUNS: 958291411
• Company Name: Fresenius Medical Care Holdings, 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: 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 bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment
• Special Storage Condition, Specify: Between 0 and 0 *This bicarbonate concentrate should be used within 24 hours of mixing.Storage in a closed container is recommended to minimize C02 loss and resulting precipitation in dialysis equipment

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861101962 [Primary]
GS1	10840861101969 [Package]; Contains: 00840861101962; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191474
• 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]

• 10840861101969: NaturaLyte Dry Pack Sodium Bicarbonate, Carton
• 00840861101955: NaturaLyte Dry Pack Sodium Bicarbonate RX 12
• 00840861101948: NaturaLyte Dry Pack Sodium Bicarbonate RX 10
• 10840861101938: NaturaLyte Liquid Sodium Bicarbonate, Case