Koala® Cables

GUDID 00814247020192

Cables to IUP catheters: HP8040A 5mV/1350

CLINICAL INNOVATIONS, LLC

Intrapartum pressure monitoring catheter

• Primary Device ID: 00814247020192
• NIH Device Record Key: d0dda55e-283c-4af9-9983-8fa1575e19b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Koala® Cables
• Version Model Number: IPC-5012
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00814247020192 [Primary]

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: 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: 2016-09-01

On-Brand Devices [Koala® Cables]

• 00814247020277: Cables to IUP catheters: Edan F6
• 00814247020260: Cables to IUP catheters: Philips Avalon
• 00814247020253: Cables to IUP catheters
• 00814247020246: Cables to IUP catheters: Neoventa
• 00814247020239: Cables to IUP catheters: Space Labs Medical 94000
• 00814247020222: Cables to IUP catheters: HP8040A 40mV
• 00814247020215: Cables to IUP catheters: Litton Air-Shields Fetascan 1400
• 00814247020208: Cables to IUP catheters: GE Coro 115/116/118
• 00814247020192: Cables to IUP catheters: HP8040A 5mV/1350