BURNSHIELD 550013
GUDID 36007645001541
BURNSHIELD MINI BURN KIT
BURNSHIELD (PTY) LTD
Synthetic polymer burn dressing, gel-coated| Primary Device ID | 36007645001541 |
| NIH Device Record Key | 3fc6b08d-eec6-4fd1-8558-db64e516f741 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BURNSHIELD |
| Version Model Number | 550013 |
| Catalog Number | 550013 |
| Company DUNS | 635842958 |
| Company Name | BURNSHIELD (PTY) LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | +27114405171 |
| sales@burnshield.com | |
| Phone | +27114405171 |
| sales@burnshield.com | |
| Phone | +27114405171 |
| sales@burnshield.com | |
| Phone | +27114405171 |
| sales@burnshield.com | |
| Phone | +27114405171 |
| sales@burnshield.com | |
| Phone | +27114405171 |
| sales@burnshield.com | |
| Phone | +27114405171 |
| sales@burnshield.com | |
| Phone | +27114405171 |
| sales@burnshield.com | |
| Phone | +27114405171 |
| sales@burnshield.com | |
| Phone | +27114405171 |
| sales@burnshield.com | |
| Phone | +27114405171 |
| sales@burnshield.com | |
| Phone | +27114405171 |
| sales@burnshield.com | |
| Phone | +27114405171 |
| sales@burnshield.com | |
| Phone | +27114405171 |
| sales@burnshield.com | |
| Phone | +27114405171 |
| sales@burnshield.com | |
| Phone | +27114405171 |
| sales@burnshield.com | |
| Phone | +27114405171 |
| sales@burnshield.com | |
| Phone | +27114405171 |
| sales@burnshield.com | |
| Phone | +27114405171 |
| sales@burnshield.com | |
| Phone | +27114405171 |
| sales@burnshield.com | |
| Phone | +27114405171 |
| sales@burnshield.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06007645001540 [Primary] |
| GS1 | 06007645002035 [Package] Contains: 06007645001540 Package: BOX [6 Units] In Commercial Distribution |
| GS1 | 26007645001544 [Package] Contains: 06007645002035 Package: BOX [16 Units] In Commercial Distribution |
| GS1 | 36007645001541 [Package] Contains: 06007645001540 Package: BOX [100 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K943728
FDA Product Code
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-03 |
| Device Publish Date | 2020-07-25 |
On-Brand Devices [BURNSHIELD]
| 06007645007917 | BURNSHIELD BLANK WOOL 1.6x1.8m(64X71") |
| 16007645007679 | BURNSHIELD CONTOUR KIT DOUBLE |
| 16007645007662 | BURNSHIELD CONTOUR KIT SINGLE |
| 26007645006358 | MUNDIAL HOME/TRAVEL KIT |
| 16007645006054 | BURNSHIELD BURN BLOTTS 0.9G |
| 16007645006047 | BURNSHIELD HYDROGEL 50ML SPRAY |
| 16007645003954 | BURNSHIELD 60X40CM FACEMASK |
| 06007645003537 | BURNSHIELD CONTOUR 1X2M |
| 16007645003527 | BURNSHIELD CONTOUR 1X1M |
| 06007645002073 | BURNSHIELD TWIN BLANKET 1.2X1.6M |
| 26007645001452 | BURNSHIELD 20X45CM FACEMASK |
| 26007645001414 | BURNSHIELD DRESS 20x45cm (8x18") |
| 16007645001400 | BURNSHIELD 60X40CM DRESSINGS |
| 06007645001397 | BURNSHIELD 20X20CM DRESSINGS |
| 96007645001383 | BURNSHIELD 10X10CM DRESSINGS IN BULK |
| 16007645000212 | BURNSHIELD BURN BLOTTS 3.5ML |
| 36007645000193 | BURNSHIELD HYD SPRAY BOTTLE 125ML(4.5oz) |
| 06007645000222 | BURNSHIELD BLANK WOOL 1.2x1.6m(48x64") |
| 16007645007655 | BURNSHIELD DRESS CONTOUR 1X2M(40X80 )BAG |
| 16007645007648 | BURNSHIELD DRESS CONTOUR 1X1M(40X40 )BAG |
| 36007645005303 | BURNSHIELD HYDROGEL TUBE 25ML (0.85 OZ) |
| 26007645004590 | BURNSHIELD HYDROGEL TUBE 10ML (0.35 OZ) |
| 36007645001541 | BURNSHIELD MINI BURN KIT |
| 06007645000161 | BURNSHIELD BLANK WOOL 2.45mx1.6m(98"X64") |
| 16007645001431 | BURNSHIELD DRESSING 25MMX0.50M (1X20") DIGIT |
| 16007645004302 | BURNSHIELD HYDROGEL SPRAY BOTTLE 75ML (2.70oz) |
| 16007645006344 | MUNDIAL DRESSING 10CMX10CM (4X4") (2'S) |
| 16007645006337 | MUNDIAL BURN KIT |
| 16007645005804 | BURNSHIELD ESSENTIAL BURN KIT LARGE |
| 16007645001424 | BURNSHIELD DRESSING 50MMX1M (2X40") LIMB |
| 16007645000120 | BURNSHIELD HYDROGEL BOTTLE 50ML (1.8OZ) |
| 16007645007921 | BURNSHIELD EMERGENCY KIT IN NYLON BAG |
| 16007645002001 | BURNSHIELD CATER KIT |
| 16007645005781 | BURNSHIELD ESSENTIAL BURN KIT SMALL |
Trademark Results [BURNSHIELD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BURNSHIELD 87262226 5399210 Live/Registered |
Levtrade International (Pty) Ltd 2016-12-08 |
 BURNSHIELD 86616015 not registered Dead/Abandoned |
Natureplex, LLC 2015-04-30 |
 BURNSHIELD 74213418 not registered Dead/Abandoned |
Levtrade International (PTY) Ltd. 1991-10-16 |
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