ThermaCor 1200 Infusion System

GUDID 20857893006091

Dual Line

SMISSON-CARTLEDGE BIOMEDICAL, LLC

Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer

• Primary Device ID: 20857893006091
• NIH Device Record Key: ba744bbe-3071-4730-9309-fa91ca0507d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermaCor 1200 Infusion System
• Version Model Number: DL-1200
• Company DUNS: 087687179
• Company Name: SMISSON-CARTLEDGE BIOMEDICAL, LLC
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com
• Phone: +1(478)330-6205
• Email: donna@t3med.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857893006097 [Primary]
GS1	10857893006094 [Package]; Contains: 00857893006097; Package: Box [8 Units]; In Commercial Distribution
GS1	20857893006091 [Package]; Contains: 10857893006094; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052055

FDA Product Code

• LGZ: Warmer, thermal, infusion fluid

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: 2016-07-15

On-Brand Devices [ThermaCor 1200 Infusion System]

• 00857893006219: European Detachable Power Cord Set
• 00857893006196: 3 Spike Set Holder
• 00857893006189: UK Detachable Power Cord Set
• 10857893006155: Drape
• 00857893006141: Rigid Fluid Reservoir Holder
• 00857893006134: Rigid Fluid Reservoir
• 20857893006121: Extension Line
• 10857893006117: 3 Spike Set
• 20857893006107: Patient Line
• 20857893006091: Dual Line
• 00857893006080: Cassette
• 10857893006070: Cassette with Dual Line
• 10857893006063: Cassette with Patient Line
• 10857893006056: Cassette with Patient Line and 3 Spike Set
• 00857893006042: Replacement Power Cord
• 00857893006035: Replacement Silpad
• 00857893006028: Replacement Footswitch
• 00857893006011: Replacement Component Guard
• 00857893006004: ThermaCor 1200 Rapid Infuser
• 00857893006226: Australia Detachable Power Cord Set