TOCO TRANSDUCER 2108347

GUDID 00840682142571

WIPRO GE HEALTHCARE PRIVATE LIMITED

Cardiotocograph transducer

• Primary Device ID: 00840682142571
• NIH Device Record Key: a76c33c6-5358-4d51-90a6-a8a40949c328
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOCO TRANSDUCER
• Version Model Number: NA
• Catalog Number: 2108347
• 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
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682142571 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982651

FDA Product Code

• HFM: MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-03
• Device Publish Date: 2018-11-01

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