DOLPHIN

GUDID 23661234017533

PEROUSE MEDICAL

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 23661234017533
• NIH Device Record Key: 20189998-55eb-49dc-b443-6588058e113b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DOLPHIN
• Version Model Number: 0185ND
• Company DUNS: 267476323
• Company Name: PEROUSE MEDICAL
• Device Count: 1
• DM Exempt: true
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661234017539 [Primary]
GS1	23661234017533 [Package]; Contains: 03661234017539; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042449

FDA Product Code

• MAV: Syringe, balloon inflation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-09-15

On-Brand Devices [DOLPHIN]

• 23661234017533: 0185ND
• 23661234017526: 0185NA