UNDERPAD QUILTED IBEX

Basic Information

• Brand Name: UNDERPAD QUILTED IBEX
• Primary DI: 00634916136456
• Version / Model: 597E7110
• Catalog Number: 597E7110
• Company Name: STANDARD TEXTILE CO., INC.
• Labeler DUNS: 006999858
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2018-01-29
• Public Version: 4
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: 8be00023-8f35-4b12-84db-085ead704f08

Device Description

UNDERPAD QUILTED IBEX KAUM 33X36 RM (98 7996) USE: 59710110

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
Primary	00634916136456	GS1
Unit of Use	10634916136453	GS1

Customer Contacts

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