Mul-T-Pad

Primary DI
10850007350090
Brand
Mul-T-Pad
Company
C2DX, INC.
Model
8002-062-612
Device description
Temperature Therapy Pad
Published
2024-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILOPack, Hot Or Cold, Water Circulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073675000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073675000T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPGaymar Industries, Inc.2008-05-08ILO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850007350090PrimaryGS10
00850007350093Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000735009010850007350090
00850007350093008500073500938500073500930850007350093

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid localized thermal therapy system pack, reusableA device intended to be applied to part of the body as part of a circulating-fluid localized thermal therapy system to provide localized heat and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It typically consists of a compact envelope that is heated and/or cooled with circulating fluid (e.g., water) from the system control unit. It is intended for use in both professional and home settings. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
888-902-2239sales@c2dx.com

Regulatory Flags#

DUNS number
116981210
Device count
10
Lot or batch
true

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