Patientstyle

Basic Information

• Brand Name: Patientstyle
• Primary DI: 00850011216002
• Version / Model: 200P CSDB O/S
• Company Name: PATIENTSTYLE MEDICAL LLC
• Labeler DUNS: 040942451
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-12
• Public Version: 1
• Public Version Date: 2019-09-20
• Public Version Status: New
• Public Device Record Key: ca001d83-2b63-4d70-bd9b-353d5c588bea
• Distribution End Date: 2025-01-31

Device Description

IV Snap Gown O/S Cross Stitch Diamonds Icy Blue. Cell Phone Pocket. Hospital 1 Embroidery.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• 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
11905	Patient gown, reusable	A garment made of natural and/or synthetic materials (e.g., cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office). A patient gown is usually short-sleeved and is closed by ties at the back/side of the garment. This is a reusable garment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850011216002	GS1