FDA.reportPublic FDA data

Medi-First Cold Spray

Primary DI
00347682230173
Brand
Medi-First Cold Spray
Company
Medique Products
Model
23017
Catalog number
23017
Device description
A non-sterile liquid in a spray container intended for localized application to the body surface to provide a cooling effect.
Published
2019-07-12
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
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
50347682230178PackageGS112In Commercial Distribution
00347682230173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5034768223017850347682230178
00347682230173003476822301733476822301730347682230173

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.

Contacts#

Phone, Email table
PhoneEmail
1-800-634-7680cs@mediqueproducts.com

Regulatory Flags#

DUNS number
086911794
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00347682713010Medi-First Large Instant Hot Pack71301713012019-07-12
00347682607012"Medi-First Waterproof Latex Free First Aid Tape 1/2"", 5 yds"60701607012019-07-03
00347682641016Medi-Stopper6401641012019-07-12
00347682696016"Medi-First Gauze Compress 24"" x 72"""69601696012019-07-19
00347682898014Medi-First Combine ABD Pad89801898012019-07-12
00347682642129Medi-First Non-Adherent Sterile Pads (10 count)64212642122019-07-12
00347682810016Medi-First Emergency Survival Blanket81001810012019-07-12
00347682623012"Medi-First Elastic Tape 1"" x 5 yards"62301623012019-07-24
00347682656997Medi-First 1/2 x 2 5 yards65699656992019-07-19
00347682660024Medi-First Tourniquet66002660022019-07-12
00347682656225Medi-First Adhesive Tape 1/2 x 2 5 yards656B656B2019-07-19
00347682135126Medi-First Plus Sterile Gauze Pads 2 x 2 (10 count)1035121035122019-07-12
00347682135737Medi-First Plus Sterile Gauze Pads 3 x 3 (25 count)1035731035732019-07-12
00347682136123Medi-First Plus Sterile Gauze Pads 3 x 3 (10 count)1036121036122019-07-12
00347682136734Medi-First Plus Sterile Gauze Pads 4 x 4 (25 count)1036731036732019-07-12
00347682137120Medi-First Plus Sterile Gauze Pads 4 x 4 (10 count)1037121037122019-07-12
00347682137731Medi-First Plus Sterile Gauze Pads 2 x 2 (25 count)1037731037732019-07-12
00347682606121Medi-First Sterile Gauze Pads 2 x 2 (10 count)60612606122019-07-12
00347682606336Medi-First Sterile Gauze Pads 3 x 3 (100 count)60633606332019-07-12
00347682606732Medi-First Sterile Gauze Pads 3 x 3 (25 count)60673606732019-07-12

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