FDA.reportPublic FDA data

Custom Medical Specialties, Inc.

Primary DI
00815849022027
Brand
Custom Medical Specialties, Inc.
Company
CUSTOM ASSEMBLIES, INC.
Model
CMS-702
Device description
Instant Ice Pack - Non-Sterile
Published
2016-11-21
Public version status
Update
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
00815849022027PackageGS120In Commercial Distribution
00815849022010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815849022027008158490220278158490220270815849022027
00815849022010008158490220108158490220100815849022010

GMDN Terms#

Term, Definition table
TermDefinition
Endothermic cold therapy packA device intended to be applied with pressure to the body surface to provide cold therapy to help reduce fever, pain, and inflammation associated with joint/muscle/tissue injury and/or minor burns. It typically consists of a compact envelope made of plastic and filled with chemicals that generate an endothermic chemical reaction when activated to reduce the temperature of the pack. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
948904735
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
00815849021556Custom Medical Specialties, Inc.CMS-1637-NS2016-11-21
00815849021839Custom Medical Specialties, Inc.CMS-5862016-11-21
00815849020917Custom Medical Specialties, Inc.CMS-9872026-10-06
00815849022768Custom Medical Specialties, Inc.CMS-9072026-10-06
00815849022775Custom Medical Specialties, Inc.CMS-910V2026-10-06
00815849022782Custom Medical Specialties, Inc.CMS-912V2026-10-06
00815849022836Custom Medical Specialties, Inc.CMS-919VT2026-10-06
00815849025288Custom Medical Specialties, Inc.CMS-3002026-10-06
00815849025363Custom Medical Specialties, Inc.CMS-20102026-10-06
00815849025493Custom Medical Specialties, Inc.CMS-954V-62026-10-06
00815849025615Custom Medical Specialties, Inc.CMS-9092026-10-06
00815849025844Custom Medical Specialties, Inc.CMS-942V2026-10-06
00815849020160Custom Medical Specialties, Inc.CMS-5102016-11-21
00815849020177Custom Medical Specialties, Inc.CMS-5152016-11-21
00815849020108Custom Medical Specialties, Inc.CMS-16372016-11-21
00815849024021Custom Medical Specialties, Inc. CMS-2732-R42023-09-14
00815849024571Custom Medical Specialties, Inc. CMS-6314-R62023-09-14
00815849023369Custom Medical Specialties, Inc. CMS-12352023-09-13
00815849023390Custom Medical Specialties, Inc. CMS-12382023-09-13
00815849023406PG-1000PG-10002023-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841445001425Diva Hot Flash PatchDiva International IncIMD2026-10-12
00841445001432Diva Hot Flash PatchDiva International IncIMD2026-10-12
00841445001449Diva Hot Flash PatchDiva International IncIMD2026-10-12
06941917859852HuayilangShandong Zhushi Pharmaceutical Group Co., Ltd. First OfficeIMD2026-10-11
00845819082003Oasis REST & RELIEF Single-UseOASIS MEDICAL, INC.IMD2026-08-14
00845819083000Oasis REST & RELIEF Plus Single-UseOASIS MEDICAL, INC.IMD2026-08-14
10080196158652MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.IMD2026-07-16
00808829131321Lucky Super SoftDELTA BRANDS INC.IMD2026-07-10
00049696561518B.PUREFOURSTAR GROUP INC.IMD2026-06-09
00049696562102B.PUREFOURSTAR GROUP INC.IMD2026-06-09
08436587170522ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-18
08436587170010ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170027ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170065ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170102ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170225ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170232ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170249ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170362ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170386ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170553ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170560ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170577ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170638ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170812ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170843ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170867ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170942ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170966ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170973ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15