FDA.reportPublic FDA data

Green Guard Deluxe Burn Kit

Primary DI
50347682011982
Brand
Green Guard Deluxe Burn Kit
Company
Greenguard
Model
1198
Catalog number
1198
Device description
1106NSB -1.000 EACH Deluxe Truck Kit Empty NS + 6254 -1.000 EACH Waterproof Tape 1"x5 yds 6117 -3.000 EACH 3" Sterile Gauze Roll 7920 --2.000 EACH Glove Wipes 3160 -3.000 EACH WJ Burn Dressing 4x4 3161 -1.000 EACH WJ Burn Dressing 4x16 3002 -2.000 EACH GG Derma Cool (2 oz.) 20669-1.000 EACH Burn Cream w/Lidocaine Unit (1 8200 -1.000 EACH 5 1/2" Band Scissors 4106 -1.000 EACH GG 8oz Eye Wash 6205 -1.000 EACH GG 3x3 Gauze Pads (10) 9010B -1.000 EACH Burn Relief Kit Stickers
Published
2019-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OJIBurn Kit With Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJIBurn Kit With DrugUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50347682011982PackageGS11In Commercial Distribution
00347682011987PrimaryGS10
03476822011987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5034768201198250347682011982
00347682011987003476820119873476820119870347682011987
03476822011987034768220119873476822011987

GMDN Terms#

Term, Definition table
TermDefinition
Burn kit, non-medicatedA collection of devices designed to treat first or second degree burns typically as first aid therapy by emergency medical services (EMS); it does not include pharmaceuticals. It typically includes burn dressings, burn gels, gauze, cold packs, adhesive tapes, and gloves; it may include additional devices such as scissors and masks. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperayure.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-869-6970cs@greenguard.com

Regulatory Flags#

DUNS number
176528040
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00347682062019Green Guard Sterile Gauze Pads620162012019-06-26
00347682620226Green Guard Sterile Gauze Pads620262022019-06-26
00347682620660Green Guard Sterile Gauze Pads620662062019-06-26
00347682621117Green Guard Sterile Gauze Pads621162112019-06-26
00347682062057Green Guard Sterile Gauze Pads620562052019-06-26
00347682062156Green Guard Non-Adherent Pads621562152019-06-26
00347682065201Green Guard Emergancy Large Wound Dressing652065202019-06-26
00347682063009Green Guard Fabric Strip Bandages630063002019-06-26
00347682063023Green Guard Fingertip Bandages630263022019-06-26
00347682063047Green Guard Knuckle Bandages630463042019-06-26
00347682063061Green Guard Large Patch Bandage 630663062019-06-26
00347682063085Green Guard Large Fingertip Bandages630863082019-06-26
00347682063108Green Guard Small Strip Bandages631063102019-06-26
00347682063122Green Guard Extra Long Fabric Strip Bandages631263122019-06-26
00347682063207Green Guard LW Bandage 1 x 3632063202019-07-19
00347682630027Green Guard HW Flexible Bandage 7/8 x 3G6300BWCG6300BWC2019-07-19
00347682630096Green Guard Blue Metal Fabric Strip Bandages6300BMD6300BMD2019-06-26
00347682630492Green Guard Blue Metal Knuckle bnadage6304BMD6304BMD2019-06-26
00347682630898Green Guard Blue Metal Large Fingertip Bandage63088BMD63088BMD2019-06-26
00347682632038Green Guard Blue Metal Fabric Strip Bandage6320BMD6320BMD2019-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00311917080048WalgreensWALGREEN CO.OJI2026-02-19
00017276235876Ozark Trail Outdoor EquipmentWAL-MART STORES, INC.OJI2019-12-16
20017276235870Ozark Trail Outdoor EquipmentWAL-MART STORES, INC.OJI2019-12-16
00347682896102Medi-First Basic Plastic Burn KitMedique ProductsOJI2019-07-19
00347682896119Medi-First Deluxe Plastic Burn KitMedique ProductsOJI2019-07-19
50347682896107Medi-First Basic Plastic Burn KitMedique ProductsOJI2019-07-19
50347682896114Medi-First Deluxe Plastic Burn KitMedique ProductsOJI2019-07-19
00347682011970Green Guard Small Burn KitGreenguardOJI2019-07-15
00347682011987Green Guard Deluxe Burn KitGreenguardOJI2019-07-15
50347682011975Green Guard Small Burn KitGreenguardOJI2019-07-15