Water-Jel CJ-BULK.77.000

GUDID 00743537001088

Cool Jel unit dose 1728 pcs/cs bulk, ASO 191317; Cool Jel

WATER-JEL TECHNOLOGIES, L.L.C.

Burn gel

• Primary Device ID: 00743537001088
• NIH Device Record Key: 028a92df-84f3-42dc-b3be-7e65edc92fa4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Water-Jel
• Version Model Number: CJ-BULK.77.000
• Catalog Number: CJ-BULK.77.000
• Company DUNS: 155522589
• Company Name: WATER-JEL TECHNOLOGIES, L.L.C.
• Device Count: 1728
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 855-428-6074
• Email: sales@safeguardmedical.com
• Phone: 855-428-6074
• Email: sales@safeguardmedical.com
• Phone: 855-428-6074
• Email: sales@safeguardmedical.com
• Phone: 855-428-6074
• Email: sales@safeguardmedical.com
• Phone: 855-428-6074
• Email: sales@safeguardmedical.com
• Phone: 855-428-6074
• Email: sales@safeguardmedical.com
• Phone: 855-428-6074
• Email: sales@safeguardmedical.com
• Phone: 855-428-6074
• Email: sales@safeguardmedical.com
• Phone: 855-428-6074
• Email: sales@safeguardmedical.com
• Phone: 855-428-6074
• Email: sales@safeguardmedical.com
• Phone: 855-428-6074
• Email: sales@safeguardmedical.com
• Phone: 855-428-6074
• Email: sales@safeguardmedical.com
• Phone: 855-428-6074
• Email: sales@safeguardmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00743537001088 [Unit of Use]
GS1	00743537001095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003396

FDA Product Code

• MGQ: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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: 2024-11-11
• Device Publish Date: 2024-11-01

On-Brand Devices [Water-Jel]

• 00743537001217: 2 oz. (59ml) Cool Jel Bottle, 24/case; Cool Jel
• 00743537001200: 4 oz. (118ml) Cool Jel Bottle, Cylinder, 24/case; Cool Jel
• 00743537001088: Cool Jel unit dose 1728 pcs/cs bulk, ASO 191317; Cool Jel
• 00743537001040: Cool Jel unit dose 1728 pcs bulk per case; Cool Jel
• 00743537001002: Cool Jel Unit Dose 100 bxs of 6 (600pcs/case)fre/eng label; Cool Jel
• 00743537000920: WJ Burn Stop 24 Boxes of 25 (600 per case); Cool Jel
• 00743537000906: Cool Jel HA Unit Dose 1728/cs; BD Gel HA
• 00743537000869: BJ HA Unit Dose German 1728/cs; BD Gel