FDA.reportPublic FDA data

KERMA

Primary DI
00612606001642
Brand
KERMA
Company
Cardinal Health 200, LLC
Model
8002
Catalog number
KR8002
Device description
Kerma Ice Bag Bilateral Facial, 5x12
Published
2026-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
KYRBAG, ICE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYRBag, IceGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10612606001649PackageGS112In Commercial Distribution
20612606001646PackageGS12In Commercial Distribution
00612606001642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061260600164910612606001649
2061260600164620612606001646
00612606001642006126060016426126060016420612606001642

GMDN Terms#

Term, Definition table
TermDefinition
Ice bagA flexible container (a bag) designed to be filled with ice to provide dry cold therapy to a limited external surface area of the body. It is typically made of plastic or rubber materials with a detachable cap that can be threaded or fixed to the bag once it is filled with ice. It may include a holder or attachments to facilitate fixing or holding the device in place against the body surface of the patient. It can be used to alleviate pain and/or promote healing in minor injuries of the body, e.g., after minor surgery, bruises, tissue swelling, or for application around the neck or limbs. This is a reusable device.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843776101843Neotech CareNEOTECH CARE INC.KYR2026-07-23
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00843776101881Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101898Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101904Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101911Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101928Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101935Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101942Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101959Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101966Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101973Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101980Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101997Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102000Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102017Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102024Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102031Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102628Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102635Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102642Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102659Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102666Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102673Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102895Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102901Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102918Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102925Neotech CareNEOTECH CARE INC.KYR2026-07-23