Crit-Line®

GUDID 00840861101139

Crit-Line in a Clip

Fresenius Usa, Inc.

Haemodialysis system blood volume monitor

• Primary Device ID: 00840861101139
• NIH Device Record Key: 7d7329c8-ba00-4629-9363-c561bd623eaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Crit-Line®
• Version Model Number: CL10041001
• 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 -40 Degrees Fahrenheit and 257 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 125 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 257 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 125 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 257 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 125 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 257 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 125 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 257 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 125 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 257 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 125 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 257 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 125 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 257 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 125 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 257 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 125 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 257 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861101139 [Primary]

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: 2
• Public Version Date: 2018-03-29
• 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