PRIMED

Basic Information

• Brand Name: PRIMED
• Primary DI: 05391534524410
• Version / Model: PM4-88335C
• Company Name: priMED Medical Products Inc
• Labeler DUNS: 253287569
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2025-07-21
• Public Version: 2
• Public Version Date: 2025-12-03
• Public Version Status: Update
• Public Device Record Key: d1d47256-e631-437f-b552-0cf7fca9ab67
• Distribution End Date: 2025-07-21

Device Description

Overhead Film Gown / Thumbloop Cuff / Open Back / Universal / Blue

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• 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
FME	Gown, Examination	General Hospital	880.6265	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32170	Professional examination gown, single-use	A garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can 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 single-use garment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05391534524427	GS1	Case	6	Not in Commercial Distribution	2025-07-21
Primary	05391534524410	GS1
Unit of Use	05391534524403	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in cool, dry, and well ventilated space out of direct sunlight.