Water-Jel CJ25-600.69.000
GUDID 00743537000920
WJ Burn Stop 24 Boxes of 25 (600 per case); Cool Jel
WATER-JEL TECHNOLOGIES, L.L.C.
Burn gel| Primary Device ID | 00743537000920 |
| NIH Device Record Key | 64f63bb0-5a26-4d12-9bf5-1ec973d7e9ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Water-Jel |
| Version Model Number | CJ25-600.69.000 |
| Catalog Number | CJ25-600.69.000 |
| Company DUNS | 155522589 |
| Company Name | WATER-JEL TECHNOLOGIES, L.L.C. |
| Device Count | 600 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00743537000920 [Unit of Use] |
| GS1 | 00743537000937 [Primary] |
| GS1 | 00743537000951 [Primary] |
| GS1 | 00743537000975 [Primary] |
| GS1 | 00743537000999 [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 |
Trademark Results [Water-Jel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WATER-JEL 73611229 1429819 Live/Registered |
TRILLING RESOURCES, LTD. 1986-07-24 |
 WATER-JEL 73526737 1391321 Dead/Cancelled |
WATER-GEL TECHNOLOGIES, INC. 1985-03-13 |
WATER-JEL 73526737 1391321 Dead/Cancelled |
TRILLING RESOURCES, LTD. 1985-03-13 |
 WATER-JEL 73522971 1392078 Live/Registered |
TRILLING RESOURCES, LTD. 1985-02-19 |
 WATER-JEL 73289821 1177931 Live/Registered |
TRILLING RESOURCES, LTD. 1980-12-15 |
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