Dermatherapy Quilted Underpad

Basic Information

• Brand Name: Dermatherapy Quilted Underpad
• Primary DI: 00634916827774
• Version / Model: 59751100
• 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: 2021-12-10
• Public Version: 3
• Public Version Date: 2023-08-22
• Public Version Status: Update
• Public Device Record Key: 474d638c-b9de-4020-8068-97d4e080713a
• Distribution End Date: 2023-06-30

Device Description

Dermatherapy Quilted Underpad with WrapPel Barrier, Non-Woven Soaker, Size 34x36

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
66117	Absorbent underpad, non-antimicrobial, reusable	A flat piece of absorbent fabric material (e.g., polyester, cotton) intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids (typically urine associated with bladder weakness/incontinence); it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10634916827771	GS1
Primary	00634916827774	GS1

Customer Contacts

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