FDA.reportPublic FDA data

Green Guard Cold Spray

Primary DI
00347682030056
Brand
Green Guard Cold Spray
Company
Greenguard
Model
3005
Catalog number
3005
Device description
A non-sterile liquid in a spray container intended for localized application to the body surface to provide a cooling effect for underlying muscles/joints to reduce pain and swelling.
Published
2019-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MLYRefrigerant, Topical (Vapocoolant)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLYVapocoolant DeviceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033720000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033720000ARI COLD SPRAYAri2005-06-10MLY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50347682030051PackageGS112In Commercial Distribution
00347682030056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5034768203005150347682030051
00347682030056003476820300563476820300560347682030056

GMDN Terms#

Term, Definition table
TermDefinition
Cold/cool therapy sprayA non-sterile liquid (e.g., alcohol based) in a spray container intended for localized application to the body surface to provide a cooling effect for underlying muscles/joints to reduce pain and swelling typically from sports injuries (cold therapy), and/or for cooling at the skin surface to treat heat rash or hot flushes (cool therapy); it may be intended to be applied to the skin directly or used in combination with a moist-cold pack/bandage (i.e., used to soak the moist-cold pack/bandage). After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not expose to temperatures above 120 C and keep away from fire or flame,

Contacts#

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

Regulatory Flags#

DUNS number
176528040
Device count
1
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

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