FDA.reportPublic FDA data

Green GuardInstant Cold Pack

Primary DI
00347682033026
Brand
Green GuardInstant Cold Pack
Company
Greenguard
Model
3302
Catalog number
3302
Device description
A device intended to be applied with pressure to the body surface to provide cold therapy - Medium
Published
2019-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMDPack, Hot Or Cold, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMDPack, Hot Or Cold, DisposablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50347682033021PackageGS148In Commercial Distribution
00347682033026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5034768203302150347682033021
00347682033026003476820330263476820330260347682033026

GMDN Terms#

Term, Definition table
TermDefinition
Endothermic cold therapy packA device intended to be applied with pressure to the body surface to provide cold therapy to help reduce fever, pain, and inflammation associated with joint/muscle/tissue injury and/or minor burns. It typically consists of a compact envelope made of plastic and filled with chemicals that generate an endothermic chemical reaction when activated to reduce the temperature of the pack. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature. Storage at cooler temperatures could cause frostbite after activation

Contacts#

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

Regulatory Flags#

DUNS number
176528040
Device count
1
Premarket exempt
true
Lot or batch
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
00049696561518B.PUREFOURSTAR GROUP INC.IMD2026-06-09
00049696562102B.PUREFOURSTAR GROUP INC.IMD2026-06-09
08436587170522ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-18
08436587170010ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170027ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170065ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170102ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170225ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170232ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170249ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170362ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170386ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170553ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170560ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170577ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170638ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170812ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170843ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170867ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170942ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170966ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170973ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171017ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171031ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171208ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171253ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171284ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171314ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171338ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171352ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15