ER-REBOA Catheter ER7232A

GUDID 00863092000118

PRYTIME MEDICAL DEVICES, INC.

Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 00863092000118
• NIH Device Record Key: 90c11054-f7e4-46d2-ad80-0ffd66f61aaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ER-REBOA Catheter
• Version Model Number: ER7232A
• Catalog Number: ER7232A
• 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: false
• Expiration Date: true
• 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	00863092000118 [Primary]

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: 2
• Public Version Date: 2019-03-21
• Device Publish Date: 2018-07-15

Devices Manufactured by PRYTIME MEDICAL DEVICES, INC.

• 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
• 00863092000118 - ER-REBOA Catheter: 2019-03-21