Koala®

GUDID 00814247020154

Koala® Intrauterine Pressure Catheter with internal balloon

CLINICAL INNOVATIONS, LLC

Intrapartum pressure monitoring catheter

• Primary Device ID: 00814247020154
• NIH Device Record Key: d89b02ce-47bf-49c5-a8d5-7533e3e25fd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Koala®
• Version Model Number: IPC-5000C
• 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	00814247020154 [Primary]
GS1	10814247020151 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	20814247020158 [Package]; Contains: 10814247020151; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974389

FDA Product Code

• HFN: Transducer, Pressure, Intrauterine

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

On-Brand Devices [Koala®]

• 20814247020172: Koala® Intrauterine Pressure Catheter with external balloon
• 00814247020154: Koala® Intrauterine Pressure Catheter with internal balloon