Compensatory Reserve Tablet T1 V2020.04.22

GUDID 00860003025611

FLASHBACK TECHNOLOGIES, INC.

Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use

• Primary Device ID: 00860003025611
• NIH Device Record Key: c4f836a7-aba9-44b3-a8ce-95009dd802ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compensatory Reserve Tablet T1 V2020.04.22
• Version Model Number: Compensatory Reserve Tablet T1 V2020.04.22
• Company DUNS: 968046099
• Company Name: FLASHBACK TECHNOLOGIES, 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00860003025611 [Primary]

FDA Product Code

• PPW: Adjunctive Cardiovascular Status Indicator

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: 2021-11-10
• Device Publish Date: 2020-05-19

Devices Manufactured by FLASHBACK TECHNOLOGIES, INC.

• 00860003025604 - CipherOx CRI: 2021-11-10 The CRI app provides the patient's individual-specific measure of the Compensatory Reserve Index.
• 00860003025611 - Compensatory Reserve Tablet T1 V2020.04.22: 2021-11-10
• 00860003025611 - Compensatory Reserve Tablet T1 V2020.04.22: 2021-11-10
• 00860003025628 - Compensatory Reserve Tablet T1 V2021.03.01: 2021-04-20