Crit-Line® 191058

GUDID 10840861102027

Blood Chamber II

Fresenius Usa, Inc.

Haemodialysis system blood volume monitor

• Primary Device ID: 10840861102027
• NIH Device Record Key: a8ddb937-dbba-418b-9437-b2d69f5b11aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Crit-Line®
• Version Model Number: 191058
• Catalog Number: 191058
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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)546-5463
• Email: crit-line@fmc-na.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861102020 [Primary]
GS1	10840861102027 [Package]; Contains: 00840861102020; Package: Box [36 Units]; In Commercial Distribution
GS1	20840861102024 [Package]; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160749

FDA Product Code

• KOC: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-04

On-Brand Devices [Crit-Line®]

• 10840861102027: Blood Chamber II
• 00840861101139: Crit-Line in a Clip
• 00840861101122: Blood Volume Monitor
• 10840861100559: Viewing window for CLiC technology