Koala Toco®

GUDID 20814247020288

Koala Toco® Single-Use Tocodyamometer

CLINICAL INNOVATIONS, LLC

Cardiotocograph transducer Cardiotocograph transducer Tocodynamometer probe Tocodynamometer probe Tocodynamometer probe Tocodynamometer probe Tocodynamometer probe Tocodynamometer probe Tocodynamometer probe Tocodynamometer probe Tocodynamometer probe Tocodynamometer probe Tocodynamometer probe

• Primary Device ID: 20814247020288
• NIH Device Record Key: 8d97ebef-8ae7-4483-a2ce-1fad790c8022
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Koala Toco®
• Version Model Number: KDT-1000
• Company DUNS: 809524291
• Company Name: CLINICAL INNOVATIONS, LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814247020284 [Primary]
GS1	10814247020281 [Package]; Contains: 00814247020284; Package: [10 Units]; In Commercial Distribution
GS1	20814247020288 [Package]; Contains: 10814247020281; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140163

FDA Product Code

• HFM: Monitor, Uterine Contraction, External (For Use In Clinic)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

Devices Manufactured by CLINICAL INNOVATIONS, LLC

• 10814247021196 - FSE: 2023-10-05 Fetal Spiral Electrode
• 00814247021205 - FSE Cables: 2023-10-05 DECG Reusable Legplate Adapter Cable
• 10814247020120 - babyLance: 2023-04-24 Preemie (Pink/White) 0.85 mm depth, Safety Heelstick
• 10814247020168 - babyLance: 2023-04-24 Micropreemie (Yellow/Green) 0.60 mm depth, Safety Heelstick
• 10814247020182 - babyLance: 2023-04-24 Newborn (Blue/Green) 1.0 mm depth, Safety Heelstick
• 10814247021127 - ABBy: 2023-04-24 ABBy Panniculus Retractor - 05 Regular
• 10814247021134 - ABBy: 2023-04-24 ABBy Panniculus Retractor - 05 Extra Large
• 10814247021141 - ABBy: 2023-04-24 ABBy Panniculus Retractor - 10 Regular