Mothership Wireless Transducers, Loop Style

GUDID 00852189007383

Kit for Fetal Ultrasonic and Tocodynamometer Monitoring includes F1 Mothership Wireless Fetal Ultrasound Transducer, Loop-Style, F1 Mothership Wireless Tocodynamometer Transducer, Loop Style, and F1 Mothership Wireless Fetal Transducer Base Station.

TENACORE HOLDINGS, INC.

Cardiotocography telemetric monitoring system receiver

• Primary Device ID: 00852189007383
• NIH Device Record Key: 0e0ab431-c6b4-44e9-81b6-38ec3e2ca0b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mothership Wireless Transducers, Loop Style
• Version Model Number: F1
• Company DUNS: 138781799
• Company Name: TENACORE HOLDINGS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852189007383 [Primary]

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: 2017-10-16

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