COROMETRICS 170 SERIES

GUDID 00840682103879

WIPRO GE HEALTHCARE PRIVATE LIMITED

Cardiotocograph Cardiotocograph Cardiotocograph Cardiotocograph Cardiotocograph Cardiotocograph Cardiotocograph Cardiotocograph Cardiotocograph Cardiotocograph Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor

• Primary Device ID: 00840682103879
• NIH Device Record Key: a4787ee3-3e96-450d-8cfb-a7a26c13222d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COROMETRICS 170 SERIES
• Version Model Number: MODEL 174
• Company DUNS: 650140403
• Company Name: WIPRO GE HEALTHCARE PRIVATE LIMITED
• 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: true
• 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(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682103879 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993751

FDA Product Code

• HGM: SYSTEM, MONITORING, PERINATAL

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: 2016-06-24

On-Brand Devices [COROMETRICS 170 SERIES]

• 00840682103879: MODEL 174
• 00840682103848: MODEL 171
• 00840682103831: MODEL 172