Crit-Line®

GUDID 00840861101122

Blood Volume Monitor

Fresenius Usa, Inc.

Haemodialysis system blood volume monitor

• Primary Device ID: 00840861101122
• NIH Device Record Key: a5bfa337-76f7-4a5d-a0ee-d6b50aa35ac2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Crit-Line®
• Version Model Number: CL10051001
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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(801)451-9000
• Email: xxx@xxx.xxx
• Phone: +1(801)451-9000
• Email: xxx@xxx.xxx
• Phone: +1(801)451-9000
• Email: xxx@xxx.xxx
• Phone: +1(801)451-9000
• Email: xxx@xxx.xxx
• Phone: +1(801)451-9000
• Email: xxx@xxx.xxx
• Phone: +1(801)451-9000
• Email: xxx@xxx.xxx
• Phone: +1(801)451-9000
• Email: xxx@xxx.xxx
• Phone: +1(801)451-9000
• Email: xxx@xxx.xxx
• Phone: +1(801)451-9000
• Email: xxx@xxx.xxx
• Phone: +1(801)451-9000
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 51 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 51 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 51 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 51 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 51 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 51 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 51 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 51 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 51 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 125 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861101122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141997

FDA Product Code

• KOC: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

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: 2016-11-17

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