Aegis Personal Protective Suit

Basic Information

• Brand Name: Aegis Personal Protective Suit
• Primary DI: 00872320005344
• Version / Model: 005-00071
• Company Name: CAO GROUP, INC.
• Labeler DUNS: 102422578
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-28
• Public Version: 1
• Public Version Date: 2020-05-06
• Public Version Status: New
• Public Device Record Key: ad6458e0-0520-4ad0-b58b-4273db77cf34

Device Description

Single use 2-piece protective suit. Extra, extra, extra, extra, extra large size.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OEA	Non-Surgical Isolation Gown	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42305	Professional examination gown, reusable	A garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. Depending upon its intended use, it may be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. This is a reusable garment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00872320005351	GS1	Pack	3	In Commercial Distribution
Primary	00872320005344	GS1