FDA.reportPublic FDA data

Green Guard Small Burn Kit

Primary DI
00347682011970
Brand
Green Guard Small Burn Kit
Company
Greenguard
Model
1197
Catalog number
1197
Device description
"1139 -1.000 EACH 10 Unit Kit Empty Plastic3160 -2.000 EACH WJ Burn Dressing 4x47920 -1.000 EACH Glove Wipes20669 -1.000 EACH Burn Cream w/Lidocaine Unit (13002 -1.000 EACH GG Derma Cool (2 oz.)6117 -1.000 EACH 3"" Sterile Gauze Roll9010B -1.000 EACH Burn Relief Kit Stickers6253 -1.000 EACH Waterproof Tape 1/2"" x 5yds6205 -1.000 EACH GG 3x3 Gauze Pads (10)"
Published
2019-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
50347682011975PackageGS11In Commercial Distribution
00347682011970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5034768201197550347682011975
00347682011970003476820119703476820119700347682011970

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 temperature.

Contacts#

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

Regulatory Flags#

DUNS number
176528040
Device count
1
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

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
00347682011987Green Guard Deluxe Burn KitGreenguardOJI2019-07-15
50347682011975Green Guard Small Burn KitGreenguardOJI2019-07-15
50347682011982Green Guard Deluxe Burn KitGreenguardOJI2019-07-15