FDA.reportPublic FDA data

Uni-Patch

Primary DI
10884527021376
Brand
Uni-Patch
Company
Cardinal Health, Inc.
Model
MV75140
Catalog number
MV75140
Device description
Compression Wrap with Gel Pack
Published
2018-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMEPack, hot or cold, reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMEPack, Hot Or Cold, ReusablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
90884527021372PackageGS110In Commercial Distribution
10884527021376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9088452702137290884527021372
1088452702137610884527021376

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal hot/cold therapy pack, reusableA non-powered device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck, nor is it designed to be dedicated to eye thermal therapy. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length48Inch
Width6Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521022171SharpSafety878187812016-09-24
30884521019298SharpSafety8836SA8836SA2016-09-24
30884521022816Monoject898989892016-09-24
40884521022752Monoject893489342016-09-24
40884521022899Monoject8985S8985S2016-09-24
10884527019649Argyle888830160688883016062016-09-24
10884527019700Argyle888830171388883017132016-09-24
10884521020511Monoject888124713788812471372018-06-30
10884521012301Monoject118030077711803007772016-09-24
10884521018266Monoject897089702016-09-24
10884521022782SharpSafety8512018512012016-09-24
10884521023253Monoject8506SA8506SA2016-09-24
10884521023369Monoject85221R85221R2016-09-24
10884521023482SharpSafety8534SA8534SA2016-09-24
10884521050310Argyle888856080588885608052016-10-06
10884521050747Argyle888856101988885610192016-09-24
10884521050754Argyle888856102788885610272016-09-24
10884521050761Argyle888856103588885610352016-09-24
10884521050778Argyle888856104388885610432016-09-24
10884521050785Argyle888856105088885610502016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850087597029Recovery+ Go Right Shoulder Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-23
00850087597036Recovery+ Go Left Shoulder Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-23
00850087597043Recovery+ Go Cervical Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-23
00850087597050Recovery+ Go Wrist Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-23
00850087597067Recovery+ Go Ankle Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-23
00850087597074Recovery+ Go Hip Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-23
00850087597012Recovery+ Go Knee Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-17
00850087597005Recovery+ Go Lumbar Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-13
00049696508339THERA PlusFOURSTAR GROUP INC.IME2026-06-09
00049696508346B.PUREFOURSTAR GROUP INC.IME2026-06-09
00050428299838CVSHealthFOURSTAR GROUP INC.IME2026-06-09
00840295411637TherabodyTherabody, Inc.IME2026-06-01
00810178885954Arctic FlexVIVE HEALTH LLCIME2026-05-06
00840397513215Sharper ImageMerchsource, LLCIME2026-04-23
307073870439893M™3M COMPANYIME2026-04-21
307073870439963M™3M COMPANYIME2026-04-21
10735282287845MunchkinMUNCHKIN, INC.IME2026-03-18
00197998026133Solventum™Solventum US LLCIME2026-02-15
00197998026164Solventum™Solventum US LLCIME2026-02-15
00197998026614Solventum™Solventum US LLCIME2026-02-15
00810178884735ViveVIVE HEALTH LLCIME2025-12-05
00810113683065ManaEZ ROM Ice ShortManamed, Inc.IME2025-10-17
00810113683515ManaEZ Hip Ice CureTechManamed, Inc.IME2025-10-03
00810113683522ManaEZ ROM Ice CureTechManamed, Inc.IME2025-10-03
00810113683539ManaEZ Shoulder Ice CureTechManamed, Inc.IME2025-10-03
00810113683638Cold Compression Wrap, Pro-Ankle WrapManamed, Inc.IME2025-09-26
00810113683645Cold Compression Wrap, Pro-Back WrapManamed, Inc.IME2025-09-26
00810113683652Cold Compression Wrap, Pro-Elbow WrapManamed, Inc.IME2025-09-26
00810113683669Cold Compression Wrap, Pro-Hip WrapManamed, Inc.IME2025-09-26
00810113683676Cold Compression Wrap, Pro-Knee WrapManamed, Inc.IME2025-09-26