Prytime Medical Devices, Inc.

GUDID 00863092000101

REBOA Catheter Convenience Set

Prytime Medical Devices, Inc.

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• Primary Device ID: 00863092000101
• NIH Device Record Key: 9784f2cc-6972-4d47-a848-0d58913180ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prytime Medical Devices, Inc.
• Version Model Number: KT1835C
• 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: true
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863092000101 [Primary]

FDA Product Code

• OFC: Catheter Introducer Kit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-01-13
• Device Publish Date: 2022-12-15

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

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