FDA.reportPublic FDA data

McKesson

Primary DI
00612479134980
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-9703
Device description
Instant Cold Pack McKesson General Purpose 6 X 9 Inch Disposable
Published
2019-04-23
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
true

Product Codes#

Code, Name table
CodeName
IMDPack, Hot Or Cold, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMDPack, Hot Or Cold, DisposablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612479134980PackageGS124In Commercial Distribution
00612479134973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479134980006124791349806124791349800612479134980
00612479134973006124791349736124791349730612479134973

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
00080196732343MEDLINEMEDLINE INDUSTRIES, INC.IMD2026-03-19
00850073571903American Hospital SupplyAmerican Hospital Supply LLCIMD2026-03-10
08806109102551Madeca Summer Aroma PatchDongkook Pharmaceutical Co.,Ltd.IMD2026-02-19
08806109102568Madeca Summer Aroma PatchDongkook Pharmaceutical Co.,Ltd.IMD2026-02-19
00885914107966Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914107973Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914107980Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914107997Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914108000Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914108017Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914108024Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914108031Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914108055Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
30665973032611DukalDukal LLCIMD2025-10-31
30665973032628DukalDukal LLCIMD2025-10-31
30860013591930Vpod EliteCool Comforts Co.IMD2025-09-24
40080196733737MEDLINEMEDLINE INDUSTRIES, INC.IMD2025-09-12
20888277659664MEDLINEMEDLINE INDUSTRIES, INC.IMD2025-09-12
00850056748490FORWARD HEAT - Life GuardINTEGRATED MEDCRAFT LLCIMD2025-09-02
40080196733362MEDLINEMEDLINE INDUSTRIES, INC.IMD2025-08-26
10860010472146Instant Cold Pack 6inx9inMedzah IndustriesIMD2025-08-11
20860012637410Instant Cold Pack 4.75x7Medzah IndustriesIMD2025-08-11
20860012637427Non-Woven Instant Cold Packs 5in x 7.5inMedzah IndustriesIMD2025-08-11
20860011917483MEDZAH INSTANT HOT PACKMedzah IndustriesIMD2025-07-30
20860012637403MEDZAH INSTANT HOT PACKMedzah IndustriesIMD2025-07-30
00850073571125American Hospital SupplyAmerican Hospital Supply LLCIMD2025-07-28
00850073571071American Hospital SupplyAmerican Hospital Supply LLCIMD2025-07-09
00840456203828JMUJMU DENTAL, INCIMD2025-06-13
16977244725048HetaidaLinqing HeTaiDa Medical Technology Co., LtdIMD2025-05-12
30860013591909VpodCool Comforts Co.IMD2025-05-02