FDA.reportPublic FDA data

sunmark

Primary DI
00010939938442
Brand
sunmark
Company
MCKESSON CORPORATION
Model
93844
Published
2021-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00010939938442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00010939938442000109399384420109399384420010939938442

GMDN Terms#

Term, Definition table
TermDefinition
Hot therapy pack heating unitA mains electricity (AC-powered) device used to heat the contents of a reusable hot therapy pack to temperatures appropriate to apply heat therapy to the human body. This device, also known as a hydrocollator, typically consists of a stainless steel container, shelves, trays, or drawers that facilitate the heating and handling of the many hot therapy packs, and heating elements that heat the packs to a specified temperature so that the they are conditioned for reuse when needed. It is typically used in accident and emergency (A&E) rooms, rehabilitation facilities and for physiotherapy treatments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
177667227
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00010939960139Foster & ThriveBP3NP1-3EMFT(2878056)2024-09-23
00010939960153Foster & ThriveBP3NU1-3EMFT(2878072)2024-09-23
00010939960177Foster & ThriveBP3MV1-3BMFT(2878098)2024-09-23
10010939960136Foster & ThriveBP3NP1-3EMFT(2878056)2024-09-23
10010939960150Foster & ThriveBP3NU1-3EMFT(2878072)2024-09-23
10010939960174Foster & ThriveBP3MV1-3BMFT(2878098)2024-09-23
00010939960191Foster & ThriveKD-1541.F&T2024-07-23
00010939960207Foster & ThriveK-955.F&T2024-07-23
00010939960214Foster & ThriveKD-2280.F&T2024-07-23
00010939960221Foster & ThriveKD-1540.F&T2024-07-23
00010939960238Foster & ThriveKD-1780-1.F&T2024-07-23
20010939960195Foster & ThriveKD-1541.F&T2024-07-23
20010939960201Foster & ThriveK-955.F&T2024-07-23
20010939960218Foster & ThriveKD-2280.F&T2024-07-23
20010939960225Foster & ThriveKD-1540.F&T2024-07-23
20010939960232Foster & ThriveKD-1780-1.F&T2024-07-23
00010939960160Foster & ThriveBP3NM1-3WMFT(2878080)2024-06-21
10010939960167Foster & ThriveBP3NM1-3WMFT(2878080)2024-06-21
00010939960146Foster & ThriveBP3NG1-1AMFT(2878064)2024-06-19
00010939960184Foster & ThriveBPAG1-20MFT(2878106)2024-06-18

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Primary DI, Brand, Company table
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00622356704953Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
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00622356710718Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356712200Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356736633Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
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