Mothership Wireless Fetal Tocodynamometer Transducer, Loop-Style

GUDID 00852189007369

Mothership Wireless Fetal Tocodynamometer Transducer, Loop-Style

TENACORE HOLDINGS, INC.

Cardiotocography telemetric monitoring system transmitter

• Primary Device ID: 00852189007369
• NIH Device Record Key: 07334a31-fc23-49f9-9269-6c5fd0920be0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mothership Wireless Fetal Tocodynamometer Transducer, 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 Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852189007369 [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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