Regard

GUDID 20326053113226

RESOURCE OPTIMIZATION & INNOVATION, L.L.C.

Fluid/device delivery cardiac catheter

• Primary Device ID: 20326053113226
• NIH Device Record Key: abc4cd04-0776-4d55-8307-8f746ed00d48
• Commercial Distribution Discontinuation: 2019-09-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Regard
• Version Model Number: HT0870
• Company DUNS: 945020902
• Company Name: RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10326053113229 [Primary]
GS1	20326053113226 [Package]; Contains: 10326053113229; Package: [3 Units]; Discontinued: 2019-09-26; Not in Commercial Distribution

FDA Product Code

• OES: Cardiac Catheterization 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: 3
• Public Version Date: 2019-09-27
• Device Publish Date: 2017-09-06

On-Brand Devices [Regard]

• 20326053113226: HT0870
• 10326053117616: AAMI LEVEL 1, PROCEDURE MASK, EARLOOP, GREEN, NON STERILE, UNIVERSAL SIZE
• 10326053117449: GOWN ISOL PULLOVER AAMI2 2XL
• 10326053117432: GOWN ISOL PULLOVER AAMI2 XL
• 10326053117425: GOWN ISOL PULLOVER AAMI2 UNIV
• 10326053117746: Goggles Without Ventilation, Universal Size
• 20326053113431: GS0904
• 10326053117760: AAMI Level 3 Surgical Gown, Reinforced SMS, Sterile XX Large
• 10326053117753: AAMI Level 3 Surgical Gown, Reinforced SMS, Sterile X Large