Prytime Medical Devices Inc.

GUDID 00850001105057

ER-REBOA Plus Balloon Occlusion Catheter

Prytime Medical Devices, Inc.

Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 00850001105057
• NIH Device Record Key: f519235e-263c-459e-9670-861d59965f69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prytime Medical Devices Inc.
• Version Model Number: ER7232PLUS
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *store in a dark, dry, cool place. avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *store in a dark, dry, cool place. avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *store in a dark, dry, cool place. avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *store in a dark, dry, cool place. avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *store in a dark, dry, cool place. avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *store in a dark, dry, cool place. avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *store in a dark, dry, cool place. avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *store in a dark, dry, cool place. avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *store in a dark, dry, cool place. avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *store in a dark, dry, cool place. avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *store in a dark, dry, cool place. avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *store in a dark, dry, cool place. avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *store in a dark, dry, cool place. avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *store in a dark, dry, cool place. avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *store in a dark, dry, cool place. avoid extended exposure to light.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001105057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193440

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

Devices Manufactured by Prytime Medical Devices, Inc.

• 00850001105125 - Prytime Medical Devices, Inc.: 2024-10-24 REBOA Catheter Compass Convenience Set
• 00850001105057 - Prytime Medical Devices Inc.: 2023-12-04ER-REBOA Plus Balloon Occlusion Catheter
• 00850001105057 - Prytime Medical Devices Inc.: 2023-12-04 ER-REBOA Plus Balloon Occlusion Catheter
• 00850001105064 - Prytime Medical Devices, Inc.: 2023-12-04 pREBOA-PRO Balloon Occlusion Catheter
• 00863092000101 - Prytime Medical Devices, Inc.: 2023-01-13 REBOA Catheter Convenience Set
• 00863092000118 - ER-REBOA Catheter: 2019-03-21