Regard

GUDID 10326053117425

GOWN ISOL PULLOVER AAMI2 UNIV

RESOURCE OPTIMIZATION & INNOVATION, L.L.C.

Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use

• Primary Device ID: 10326053117425
• NIH Device Record Key: 2405ccc2-0aa1-49aa-8216-72db25ee400c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regard
• Version Model Number: A2ISOGULNS-REG
• Company DUNS: 134472476
• Company Name: RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00326053117428 [Primary]
GS1	10326053117425 [Package]; Contains: 00326053117428; Package: [100 Units]; In Commercial Distribution

FDA Product Code

• OEA: Non-Surgical Isolation Gown

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-25
• Device Publish Date: 2020-05-15

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