FDA.reportPublic FDA data

MPM CoolMagic

Primary DI
00366977206334
Brand
MPM CoolMagic
Company
Mpm Medical, LLC
Model
3
Catalog number
MP00206
Device description
MPM CoolMagic Clear Hydogel Sheet Wound Drsg 3.75X3.75. Package configuration: 10 Dressings. Per sbs; 3 sbs per case.
Published
2022-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973693000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973693000AQUA PATCHPci Technology1997-12-18MGQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00366977206334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00366977206334003669772063343669772063340366977206334

GMDN Terms#

Term, Definition table
TermDefinition
Genital inflammation/infection hydrogel dressingA gel intended to be applied to the skin or mucosa to treat inflammation/infection of the external genitalia (e.g., vulvitis and balanitis) through hydration and infection control properties (e.g., microbial binding, persistent barrier to help prevent secondary infection). It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8002325512Info@mpmmed.com

Regulatory Flags#

DUNS number
081241522
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00366977010252CoMatryx Surgical Bovine Type 1 Collagen 2.5mL1COM102022-12-07
00366977020053CoMatryx Surgical Bovine Type 1 Collagen2COM202022-12-07
00366977020503MetaMatrix Surgical Bovine Type 1 Collagen2META202022-12-07
00366977102506MetaMatrix Surgical Bovine Type 1 Collagen2META102022-12-07
00366977310222MPM Triple Helix Collagen Drsg 2X21MP003102022-12-07
00366977311014Triple Helix Collagen Powder6MP003112022-12-07
00366977312127"MPM Triple Helix Collagen Wound Drsg 12"" Rope"1MP003122022-12-07
00366977314442MPM Triple Helix Collagen Dressing 4x41MP003142022-12-07
00366977315012MPM Triple Helix Collagen Powder2mp003152022-12-07
00366977329828ACM Surgical Collagen1MP003292022-12-07
00366977333337ACM Surgical Collagen1MP003332022-12-07
00366977334457ACM Surgical Extra Advanced Collagen2MP003342022-12-07
00366977337779ACM Surgical Extra Collagen2MP003372022-12-07
00366977345019ACM Surgical Collagen2MP003452022-12-07
00366977377775MPM Medical2MP003772022-12-07
00366977140454MPM SilverMed Antimicrobial Hydrogel2ABSM14042022-12-07
00366977141031MPM SilverMed3ABSM14102022-12-07
00366977141581MPM SilverMed3ABSM14152022-12-07
00366977208680MPM Cool Magic6MP002082022-12-07
00366977140157MPM SilverMed Antimicrobial Hydrogel3ABSM14062022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00368040753141Promiseb Topical CreamPrimus Pharmaceuticals, Inc.MGQ2026-05-01
00850058790114RV-X1Gel4med, Inc.MGQ2025-10-17
00850058790121RV-X1Gel4med, Inc.MGQ2025-10-17
00850058790138G4Derm PlusGel4med, Inc.MGQ2025-10-17
00850058790145G4Derm PlusGel4med, Inc.MGQ2025-10-17
00850058790152G4Derm PlusGel4med, Inc.MGQ2025-10-17
00383160000104Dash TopicAIM MEDICAL INC.MGQ2025-05-12
00850058790060SuprelloGel4med, Inc.MGQ2025-03-25
00850058790084SuprelloGel4med, Inc.MGQ2025-03-25
00850058790091SuprelloGel4med, Inc.MGQ2025-03-25
00860013569907MuGardSoleva Pharma LLCMGQ2025-02-28
00743537000791BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000814BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000838BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000852Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000913Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000937Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000951Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000975Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000999Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001019Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001033Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001057Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001071Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001095Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000784BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000807BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000821BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000845Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000906Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01