FDA.reportPublic FDA data

HCS

Primary DI
10810132040075
Brand
HCS
Company
Concordance Healthcare Solutions LLC
Model
HCS1108
Device description
Ice Bag w/Clip Closure & Ties, Large, 7” x 16.5”, Latex Free
Published
2023-05-19
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
KYRBag, Ice

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYRBag, IceGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810132040075PackageGS12In Commercial Distribution
00810132040078PrimaryGS10
20810132040072Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081013204007510810132040075
00810132040078008101320400788101320400780810132040078
2081013204007220810132040072

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
080220245
Device count
25
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00810132043789HCS9201-5002026-05-13
00810132043796HCS9201-10002026-05-13
00810132044359HCS3004OHCB23004OHCB22026-03-09
00810132044366HCS Sourcing3004OTCB2XL3004OHCB2XL2026-03-09
00810132044335HCS3011SHU3011SHU2026-03-09
00810132044342HCS3011SHXL3011SHXL2026-03-09
10810132044332HCS3011SHU3011SHU2026-03-09
10810132044349HCS3011SHXL3011SHXL2026-03-09
10810132044356HCS3004OHCB22026-03-09
20810132044360HCS Sourcing3004OTCB2XL2026-03-09
10810132043717HCS6605W2026-01-30
10810132043724HCS6606W2026-01-30
00810132040030HCSHCS40032023-04-21
00810132040047HCSHCS40042023-04-21
00810132040979HCSHCS40012023-04-21
00810132040986HCSHCS40022023-04-21
20810132043714HCS6605W2026-01-30
20810132043721HCS6606W2026-01-30
00810132043000HCS818012026-01-23
00810132043017HCS818022026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843776101843Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101850Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101867Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101874Neotech CareNEOTECH CARE INC.KYR2026-07-23
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