Bibag 08-4078-BB

GUDID 10840861101310

Bibag Dry Sodium Bicarbonate

Fresenius Medical Care Holdings, Inc.

Haemodialysis concentrate

• Primary Device ID: 10840861101310
• NIH Device Record Key: 97b22a64-2353-4010-ba24-eca78e320012
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bibag
• Version Model Number: 08-4078-BB
• Catalog Number: 08-4078-BB
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate. Keep bag tightly sealed until it is connected to the hemodialysis machine

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861101313 [Primary]
GS1	10840861101310 [Package]; Contains: 00840861101313; Package: [16 Units]; In Commercial Distribution

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: 4
• Public Version Date: 2020-03-16
• Device Publish Date: 2015-10-02

On-Brand Devices [Bibag]

• 10840861101310: Bibag Dry Sodium Bicarbonate
• 10840861101327: Bibag Dry Sodium Bicarbonate