FDA.reportPublic FDA data

Green Guard Cold Spray

Primary DI
50347682030051
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
Rx
false
OTC
false
Sterile
false
Single use
false

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,

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
false
HCT/P
false
Kit
false
Combination product
false
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

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