FDA.reportPublic FDA data

Medi-First Cold Spray

Primary DI
50347682230178
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
Rx
false
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
086911794
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
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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