MedSource Pillow Case

Basic Information

• Brand Name: MedSource Pillow Case
• Primary DI: 00840155401341
• Version / Model: MS-44125
• Catalog Number: Not Applicable
• Company Name: MEDSOURCE INTERNATIONAL LLC
• Labeler DUNS: 041674552
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-07
• Public Version: 2
• Public Version Date: 2022-07-04
• Public Version Status: Update
• Public Device Record Key: 163ddf37-3f05-4d7b-8114-8a8334bfa140

Device Description

Poly-Tissue Pillow Case

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: 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
KME	Bedding, Disposable, Medical	General Hospital	880.6060	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47453	Basic pillowcase, reusable	A protective envelope for a pillow typically made of a thin textile material intended to create a physical barrier to soiling and cross-contamination. It does not include antimicrobial/probiotic materials but might provide a physical barrier (e.g., tight weave) to dust mites. The device is laundered for cleaning, usually at regular intervals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00840155401358	GS1	Case	100	In Commercial Distribution
Primary	00840155401341	GS1