Tenacore

GUDID 00852189007024

Corometrics Nautilus TOCO for 116, 118, 120 series, 150, 170 series monitors W/KNOB

TENACORE HOLDINGS, INC.

Cardiotocograph

• Primary Device ID: 00852189007024
• NIH Device Record Key: 35608c71-f179-4f7b-ad33-c7eebb62d0c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tenacore
• Version Model Number: TFCT-CM03-0201
• 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	00852189007024 [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: 2016-10-17

On-Brand Devices [Tenacore]

• 00861269000213: Low flow Oxygen blender
• 00861269000206: High-Low Flow Oxygen Blender
• 00852189007147: Corometrics Ultrasound for 115/145 monitors W/WINGS AND KNOB
• 00852189007109: Corometrics Ultrasound for 116, 118, 120 series monitors W/WINGS 5700
• 00852189007093: Corometrics Nautilus Ultrasound for 116, 118, 120 series, 150, 170 series monitors W/WING 8′
• 00852189007086: Corometrics Nautilus Ultrasound for 116, 118, 120 series, 150, 170 series monitors W/KNOB
• 00852189007079: HP/Philips M1356A Ultrasound W/HORSESHOE AND KNOB
• 00852189007055: HP/Philips 8040 Ultrasound W/HORSESHOE AND KNOB
• 00852189007048: Corometrics 2260 TOCO for 116, 118, 120 series monitors W/WINGS
• 00852189007031: Corometrics Nautilus TOCO for 116, 118, 120 series, 150, 170 series monitors W/WING
• 00852189007024: Corometrics Nautilus TOCO for 116, 118, 120 series, 150, 170 series monitors W/KNOB
• 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