Kolbs

GUDID 00816554010378

Kolbs Gel Overlay

K2 Health Products LLC

Gel-filled bed mattress overlay Gel-filled bed mattress overlay Gel-filled bed mattress overlay Gel-filled bed mattress overlay Gel-filled bed mattress overlay Gel-filled bed mattress overlay Gel-filled bed mattress overlay Gel-filled bed mattress overlay Gel-filled bed mattress overlay Gel-filled bed mattress overlay Gel-filled bed mattress overlay Gel-filled bed mattress overlay

• Primary Device ID: 00816554010378
• NIH Device Record Key: 5e003543-b3d6-4941-958c-49f14e46b640
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kolbs
• Version Model Number: KGELO
• Company DUNS: 800616612
• Company Name: K2 Health Products LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(718)451-4444
• Email: info@k2health.com
• Phone: +1(718)451-4444
• Email: info@k2health.com
• Phone: +1(718)451-4444
• Email: info@k2health.com
• Phone: +1(718)451-4444
• Email: info@k2health.com
• Phone: +1(718)451-4444
• Email: info@k2health.com
• Phone: +1(718)451-4444
• Email: info@k2health.com
• Phone: +1(718)451-4444
• Email: info@k2health.com
• Phone: +1(718)451-4444
• Email: info@k2health.com
• Phone: +1(718)451-4444
• Email: info@k2health.com
• Phone: +1(718)451-4444
• Email: info@k2health.com
• Phone: +1(718)451-4444
• Email: info@k2health.com
• Phone: +1(718)451-4444
• Email: info@k2health.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816554010378 [Primary]

FDA Product Code

• IKY: MATTRESS, FLOTATION THERAPY, NON-POWERED

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-18
• Device Publish Date: 2022-08-10

Devices Manufactured by K2 Health Products LLC

• 10816554013987 - Inspire: 2022-11-22 Inspire Black Exam Grade Nitrile Gloves Size Small
• 10816554013994 - Inspire: 2022-11-22 Inspire Black Exam Grade Nitrile Gloves Size Medium
• 10816554014007 - Inspire: 2022-11-22 Inspire Black Exam Grade Nitrile Gloves Size Large
• 10816554014014 - Inspire: 2022-11-22 Inspire Black Exam Grade Nitrile Gloves Size X-Large
• 10816554014021 - Inspire: 2022-11-22 Inspire Premium 6 MIL Black Exam Grade Nitrile Gloves Size Small
• 10816554014038 - Inspire: 2022-11-22 Inspire Premium 6 MIL Black Exam Grade Nitrile Gloves Size Medium
• 10816554014045 - Inspire: 2022-11-22 Inspire Premium 6 MIL Black Exam Grade Nitrile Gloves Size Large
• 10816554014052 - Inspire: 2022-11-22 Inspire Premium 6 MIL Black Exam Grade Nitrile Gloves Size X-Large