Kolbs

Basic Information

• Brand Name: Kolbs
• Primary DI: 00816554010378
• Version / Model: KGELO
• Company Name: K2 Health Products LLC
• Labeler DUNS: 800616612
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-10
• Public Version: 1
• Public Version Date: 2022-08-18
• Public Version Status: New
• Public Device Record Key: 5e003543-b3d6-4941-958c-49f14e46b640

Device Description

Kolbs Gel Overlay

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IKY	MATTRESS, FLOTATION THERAPY, NON-POWERED	General Hospital	880.5150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44594	Gel-filled bed mattress overlay	A gel-filled pad or thin mattress, usually full-body length, which is placed on top of a bed mattress to distribute an occupant's body weight over a large surface area, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816554010378	GS1

Customer Contacts

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