FDA.reportPublic FDA data

A Plus

Primary DI
80683534040016
Brand
A Plus
Company
A PLUS INTERNATIONAL INC.
Model
1
Catalog number
44-0040-8718-3
Device description
3M Hot Cold Pack - Nylon Cover, Bulk, 1000 PCS/CS
Published
2024-01-18
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
80683534040016PackageGS11000In Commercial Distribution
00683534040010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
8068353404001680683534040016
00683534040010006835340400106835340400100683534040010

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
191705904
Device count
1
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
00683534820513A Plus19206-JB2022-10-19
00683534820544A Plus1OR-1740-JB2022-10-19
00683534040010A Plus144-0040-8718-32024-01-18
00683534040027A Plus144-0040-8719-12024-01-18
00683534040034A Plus170-2004-4277-32024-01-18
00683534090336RegardA3PMSKUL4-REG2025-08-06
00683534090343RegardA3PMSKUL4-REG2025-08-06
00683534850015A Plus1SEP1525-12022-10-19
00683534850022A Plus1SNA0304-12022-10-19
00683534850039A Plus1SAB0810-12022-10-19
00683534850046A Plus1SAB0875-12022-10-19
00683534850053A Plus1AB0509-N2022-10-19
00683534850060A Plus1AB0810-N2022-10-19
00683534850077A Plus1AB0875-N2022-10-19
00683534850084A Plus1NG-2204-32022-10-19
00683534850091A Plus1NG-3304-32022-10-19
00683534850107A Plus1NG-4404-32022-10-19
00683534850114A Plus1SDR4406-22022-10-19
00683534850121A Plus1SIV2206-22022-10-19
00683534850138A Plus1NG-2203-32022-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612606001642KERMACardinal Health 200, LLCKYR2026-01-29
10612606001649KERMACardinal 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
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