PrimaPro

Basic Information

• Brand Name: PrimaPro
• Primary DI: 00850022371516
• Version / Model: PE-3745-XL
• Company Name: PRIMARY PRODUCTS COMPANY
• Labeler DUNS: 089569581
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2020-09-18
• Public Version: 3
• Public Version Date: 2021-08-25
• Public Version Status: Update
• Public Device Record Key: 8b910a9d-ae6c-4615-a484-c5a5288dc9bb

Device Description

PrimaPro GentleWare Polyethylene Isolation Gown with Thumbholes XL, 15 Gowns/Box, 5 Box/Case, 75 Gowns/Case, Single Use

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: Yes
• 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
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	10850022371513	GS1	Case	5	In Commercial Distribution
Primary	00850022371516	GS1
Unit of Use	20850022371510	GS1