FDA.reportPublic FDA data

McKesson

Primary DI
00612479228924
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-6115
Device description
Hot & Cold Compress 2.5 in x 5 in
Published
2019-04-24
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
false

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
00612479228924PackageGS1150In Commercial Distribution
00612479228917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479228924006124792289246124792289240612479228924
00612479228917006124792289176124792289170612479228917

GMDN Terms#

Term, Definition table
TermDefinition
Hot/cold therapy pack, single-useA non-sterile 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, peat) 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. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998026140Solventum™Solventum US LLCIME2026-02-15
00197998026171Solventum™Solventum US LLCIME2026-02-15
00197998026621Solventum™Solventum US LLCIME2026-02-15
00197998320255Solventum™Solventum US LLCIME2026-02-15
00810178881840Arctic FlexVIVE HEALTH LLCIME2026-02-05
00818323024869Arctic FlexVIVE HEALTH LLCIME2026-02-03
00885914107898Sammons PrestonPerformance Health Supply, LLCIME2026-01-23
06973641884206CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884213CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884220CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884237CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884244CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884251CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884268CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884275CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884282CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884299CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884305CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884312CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884329CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884336CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884343CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884350CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884367CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884374CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884381CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884398CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884404CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884411CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884428CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22