Prytime Medical Devices, Inc.

GUDID 00850001105064

pREBOA-PRO Balloon Occlusion Catheter

Prytime Medical Devices, Inc.

Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 00850001105064
• NIH Device Record Key: c777d686-54cb-4c8f-b570-0953475f7d01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prytime Medical Devices, Inc.
• Version Model Number: PRP7226PRO
• Company DUNS: 050741500
• Company Name: Prytime Medical Devices, 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: 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	00850001105064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200459

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

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: 2023-12-04
• Device Publish Date: 2022-12-15

On-Brand Devices [Prytime Medical Devices, Inc.]

• 00863092000101: REBOA Catheter Convenience Set
• 00850001105064: pREBOA-PRO Balloon Occlusion Catheter
• 00850001105125: REBOA Catheter Compass Convenience Set