FDA.reportPublic FDA data

KERMA

Primary DI
10612606001649
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
Rx
false
OTC
true
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197106911266CARDINAL HEALTHSBA60POLHCSBA60POLHC2026-06-08
10197106983577CARDINAL HEALTHSEN69ERMVDSEN69ERMVD2026-06-08
10198956182264CARDINAL HEALTHSCV43OOTGKSCV43OOTGK2026-06-08
10198956218611CARDINAL HEALTHSOP55AOKFJSOP55AOKFJ2026-06-08
10198956227552CARDINAL HEALTHSEY33EPCAFSEY33EPCAF2026-06-08
10198956279391CARDINAL HEALTH01-0111A01-0111A2026-06-08
10198956312920CARDINAL HEALTHSMA57CESARSMA57CESAR2026-06-08
10198956332096CARDINAL HEALTHSOP32THGMLSOP32THGML2026-06-08
10198956336865CARDINAL HEALTHPN73CRKPBPN73CRKPB2026-06-08
10198956343139CARDINAL HEALTHSOP45HAOCCSOP45HAOCC2026-06-08
10198956359024CARDINAL HEALTHSBA24UPJRGSBA24UPJRG2026-06-08
10198956362932CARDINAL HEALTHSEN48TASABSEN48TASAB2026-06-08
10198956364349CARDINAL HEALTHSBACGRPGRASBACGRPGRA2026-06-08
10198956364783CARDINAL HEALTHSNE38LMCIBSNE38LMCIB2026-06-08
10198956373372CARDINAL HEALTHSOP31EXHNGSOP31EXHNG2026-06-08
10198956373976CARDINAL HEALTHSOP38SHUSHSOP38SHUSH2026-06-08
10198956374119CARDINAL HEALTHSBA56LPSTCSBA56LPSTC2026-06-08
10198956386150CARDINAL HEALTHSEN69SPREBSEN69SPREB2026-06-08
10198956387171CARDINAL HEALTHSBA41PLRSESBA41PLRSE2026-06-08
10198956390430CARDINAL HEALTHSEN37TSPSDSEN37TSPSD2026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612606001642KERMACardinal Health 200, LLCKYR2026-01-29
00885914108062Sammons Preston Performance Health Supply, LLCKYR2026-01-23
00885914108079Sammons PrestonPerformance Health Supply, LLCKYR2026-01-23
10860001416715Chemo MouthpieceCHEMOMOUTHPIECE, LLCKYR2024-05-22
10860001416722Denta-CoolCHEMOMOUTHPIECE, LLCKYR2024-05-22
10860001416739Chemo MouthpieceCHEMOMOUTHPIECE, LLCKYR2024-05-22
00683534040010A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
00683534040027A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
00683534040034A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
80683534040016A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
80683534040023A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
80683534040030A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
M20890046941CUSTOMEDCUSTOMED INCKYR2023-08-10
M20890046951CUSTOMEDCUSTOMED INCKYR2023-08-10
M20890046942CUSTOMEDCUSTOMED INCKYR2023-08-10
M20890046952CUSTOMEDCUSTOMED INCKYR2023-08-10
00810132040061HCSConcordance Healthcare Solutions LLCKYR2023-05-19
00810132040078HCSConcordance Healthcare Solutions LLCKYR2023-05-19
10810132040068HCSConcordance Healthcare Solutions LLCKYR2023-05-19
10810132040075HCSConcordance Healthcare Solutions LLCKYR2023-05-19
00057475570095BIOS LivingThermor LtdKYR2023-03-31
10057475570092BIOS LivingThermor LtdKYR2023-03-31
00049696507806THERA PlusFOURSTAR GROUP INC.KYR2023-02-05
06975306620013Magic gelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306620020magicgelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306620037magicgelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306620044magicgelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306620051magicgelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306620068magicgelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306622024Magic gelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25