UNDERPAD INTEGRITY PLUS

Basic Information

• Brand Name: UNDERPAD INTEGRITY PLUS
• Primary DI: 00634916116977
• Version / Model: 59797900
• Catalog Number: 59797900
• Company Name: STANDARD TEXTILE CO., INC.
• Labeler DUNS: 006999858
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2018-01-29
• Public Version: 4
• Public Version Date: 2023-06-30
• Public Version Status: Update
• Public Device Record Key: a638f2e9-e7be-4873-befc-4c1607dc0562
• Distribution End Date: 2018-01-29

Device Description

UNDERPAD INTEGRITY PLUS KAUM 33X36 RM (98 7798) USE: 59782100

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
FMW	Cover, Mattress (Medical Purposes)	General Hospital	880.6190	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47455	Basic bed sheet, reusable	A large piece of fabric material intended to cover the mattress of a bed to protect it from being soiled and to provide the bed's occupant with clean, non-irritating contact surfaces (over and under); it does not include antimicrobial or nonadherent properties. It is typically made of a thin-textile or reinforced-paper material and is laundered for cleaning between periods of use. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00634916116977	GS1
Unit of Use	10634916116977	GS1

Customer Contacts

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