Tenacore

GUDID 00852189007017

HP/Philips M1355A TOCO W/HORSESHOE AND KNOB with 12 Pin Round Connector

TENACORE HOLDINGS, INC.

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: 00852189007017
• NIH Device Record Key: 1f73fc90-f5d3-4488-af12-a254f1e50f28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tenacore
• Version Model Number: TFCT-PH05-2303
• Company DUNS: 138781799
• Company Name: TENACORE HOLDINGS, INC.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852189007017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043075

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-29

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• 00852189007017: HP/Philips M1355A TOCO W/HORSESHOE AND KNOB with 12 Pin Round Connector
• 00852189007000: HP/Philips 8040 TOCO W/HORSESHOE AND KNOB with 12 Pin Round Connector