Regard

GUDID 20194717116742

Open Heart Supply

ROI CPS, LLC

Cardiothoracic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 20194717116742
• NIH Device Record Key: 5c25dac5-59e0-48d4-bbff-768e5233e90c
• Commercial Distribution Discontinuation: 2025-04-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Regard
• Version Model Number: CV00966C
• Company DUNS: 117174678
• Company Name: ROI CPS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10194717116745 [Primary]
GS1	20194717116742 [Package]; Contains: 10194717116745; Package: [2 Units]; Discontinued: 2025-04-09; Not in Commercial Distribution

FDA Product Code

• OEZ: Cardiovascular Procedure Kit

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: 2025-04-10
• Device Publish Date: 2023-01-19

On-Brand Devices [Regard]

• 20194717108877: Craniotomy
• 20194717108846: Spine Pack
• 20194717108839: Isolation Kit
• 20194717108730: CV 2 A&B
• 20194717108884: Cysto
• 20194717108860: Cervical
• 20194717108853: Minor Ortho
• 20194717108785: C-Section
• 20194717108778: C-Section
• 20194717108945: Open Heart Supply
• 20194717108938: Hip Arthroscopy
• 20194717108921: Anesthesia Bundle
• 20194717108914: CCOR Hand
• 20194717108907: Stereotactic
• 20194717108891: Pacemaker
• 20194717108822: LAMINECTOMY
• 20194717108761: Knee Artho
• 20194717108754: Total Knee
• 20194717108716: GYN/LAPAROSCOPY
• 20194717108723: Laminectomy
• 20194717114038: STEREOTACTIC KIT
• 20194717115424: Cervical
• 20194717115400: Spine Pack
• 20194717115974: Cervical
• 20194717115967: Spine Pack
• 20194717115936: Minor Ortho
• 20194717116056: Spine Pack
• 20194717115387: Craniotomy
• 20194717117312: Cervical Pack
• 20194717118678: Cervical Pack
• 20194717118890: Craniotomy
• 20194717118852: Spine Pack
• 20194717108648: Shuntagram
• 20194717116742: Open Heart Supply