BurnFree SD20.00.000

GUDID 00743537000760

BurnFree 20, 3.5g, 20pc/bx 30bx/cs; BD Gel

WATER-JEL TECHNOLOGIES, L.L.C.

Burn gel

• Primary Device ID: 00743537000760
• NIH Device Record Key: 49b9b408-05bf-4edb-9f35-f41ad892837c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BurnFree
• Version Model Number: SD20.00.000
• Catalog Number: SD20.00.000
• Company DUNS: 155522589
• Company Name: WATER-JEL TECHNOLOGIES, L.L.C.
• Device Count: 30
• 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: true
• 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
• Phone: 855-428-6074
• Email: sales@safeguardmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00743537000760 [Unit of Use]
GS1	00743537000777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990180

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: 2024-11-08
• Device Publish Date: 2024-10-31

On-Brand Devices [BurnFree]

• 00743537000012: Int'l BurnFree 36"X30", 91x76cm Fire/Trauma Blanket
• 00743537000005: BurnFree 72"X60", 183x152cm Fire/Trauma Blanket
• 00743537000050: BurnFree 96"X60", 244x152cm Fire/Trauma Blanket
• 00743537000289: BurnFree 20cm x 20cm French (8"X8") Burn Dressing 30 pcs/cs; BD Gel
• 00743537000739: HA Military Universal Dressing (20 pcs/cs); BD Gel
• 00743537000623: NEW Burn Stop 8"x8" dressing 50/case (REF BSD400R); BD Gel
• 00743537000616: Burn Stop 8"x20" dressing 20/case (REF BSD1000R); BD Gel
• 00743537000609: WJ Burn Stop BD 4"x4", 100/cs; BD Gel
• 00743537000593: BurnFree 30cm x 40cm (12"X16") Burn Dressing 20/cs; BD Gel
• 00743537000586: BurnFree 30cm x 30cm (12"X12") Burn Dressing 20/cs; BD Gel
• 00743537000579: BurnFree 20cm x 45cm (8"X18") Burn Dressing 20/cs; BD Gel
• 00743537000272: BurnFree 10cm x 40cm (4"X16") Burn Dressing 20/cs; BD Gel
• 00743537000234: BurnFree 10cm x 10cm (4"X4") Burn Dressing 60/cs; BD Gel
• 00743537000173: BurnFree 5cm x 15cm (2"X6") Burn Dressing 60/cs; BD Gel
• 00743537000098: BurnFree 5cm x 5cm (2"X2") Burn Dressing 400/cs; BD Gel
• 00743537000760: BurnFree 20, 3.5g, 20pc/bx 30bx/cs; BD Gel
• 00743537000821: BurnFree SD, 3.5g 1,000/cs; BD Gel
• 00743537000807: BurnFree SD, 3.5g, 6pc/bx 100bx/cs; BD Gel
• 00743537000784: BurnFree SD, 3.5g, 25pc/bx 24bx/cs; BD Gel