Primary Device ID | 00743537000289 |
NIH Device Record Key | c8458b63-0e0b-4ca4-a2de-ecc3812bfd7a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | BurnFree |
Version Model Number | 202030F.00.000 |
Catalog Number | 202030F.00.000 |
Company DUNS | 155522589 |
Company Name | WATER-JEL TECHNOLOGIES, L.L.C. |
Device Count | 30 |
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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00743537000289 [Unit of Use] |
GS1 | 00743537000296 [Primary] |
GS1 | 00743537000562 [Primary] |
NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-11-04 |
Device Publish Date | 2024-10-25 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BURNFREE 78148816 not registered Dead/Abandoned |
Holmes, Carl 2002-07-30 |
BURNFREE 78033166 not registered Dead/Abandoned |
Flame Safe Fabric Specialists Pty. Ltd. 2000-10-31 |