Mini Telemetry System

GUDID 00840682117012

WIPRO GE HEALTHCARE PRIVATE LIMITED

Cardiotocography telemetric monitoring system

• Primary Device ID: 00840682117012
• NIH Device Record Key: e1671413-b34f-48ae-b1aa-8b691a1fd8e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mini Telemetry System
• Version Model Number: 2051440-003
• 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(414)355-5000
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682117012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110556

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: 4
• Public Version Date: 2019-12-10
• Device Publish Date: 2016-06-24

On-Brand Devices [Mini Telemetry System]

• 00840682117166: 2051440-001
• 00840682117128: 2051440-002
• 00840682117067: 2051440-004
• 00840682117012: 2051440-003
• 00840682116992: 2051444-004
• 00840682117173: 2051444-001
• 00840682117111: 2051444-003
• 00840682117081: 2051444-002