COVER FOR 6946, 6947 TEMPUR PILLOW

Basic Information

• Brand Name: COVER FOR 6946, 6947 TEMPUR PILLOW
• Primary DI: 10842430110877
• Version / Model: 6947-1
• Catalog Number: 6947-50
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Labeler DUNS: 084527241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2019-09-06
• Public Version: 2
• Public Version Date: 2022-07-04
• Public Version Status: Update
• Public Device Record Key: d88545eb-40bb-4b48-9595-bb2918b81f28

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
KME	Bedding, Disposable, Medical	General Hospital	880.6060	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47454	Basic pillowcase, single-use	A protective envelope for a pillow typically made of a thin-textile or reinforced-paper 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. This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10842430110877	GS1
Unit of Use	00842430110870	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]