FDA.reportPublic FDA data

Arctic Flex

Primary DI
00810041987907
Brand
Arctic Flex
Company
VIVE HEALTH LLC
Model
RHB1055
Device description
Knee Hot and Cold Pack
Published
2021-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IMEPack, Hot Or Cold, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMEPack, Hot Or Cold, ReusablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810041987904PackageGS112In Commercial Distribution
00810041987907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198790410810041987904
00810041987907008100419879078100419879070810041987907

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
047025993
Device count
1
DM exempt
true
Premarket exempt
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810226443068ViveLVA1006GBU2026-10-22
00810226443075ViveLVA1006PBU2026-10-22
00810226443082ViveSUP3196BLKSM2026-10-22
00810226443099ViveSUP3196BLKLXL2026-10-22
00810226443037ViveMOB1170BLK2026-10-21
00810226443044ViveMOB1170PUR2026-10-21
00810226443051ViveMOB1170TAL2026-10-21
00810226442719ViveMOB1168GRYLTH2026-10-20
00810226442726ViveMOB1168GRYAC2026-10-20
00810226443006ViveSUP3194ORG362026-10-20
00810226443013ViveSUP3195BLKSM2026-10-20
00810226443020ViveSUP3195BLKLXL2026-10-20
00810226442825ViveSUP3190BLKS2026-10-15
00810226442832ViveSUP3190BLKM2026-10-15
00810226442849ViveSUP3190BLKL2026-10-15
00810226442979Vive CareRHB3085PAK102026-10-14
00810226442870ViveSUP3192BLKS2026-10-12
00810226442887ViveSUP3192BLKM2026-10-12
00810226442894ViveSUP3192BLKL2026-10-12
00810226442900ViveSUP3192BLKXL2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03858894530069Thigh Thermic WrapZAMAR MEDICAL d.o.o.IME2026-10-12
03858894530083Knee/Calf Thermic WrapZAMAR MEDICAL d.o.o.IME2026-10-12
03858894530106Lumbar Thermic WrapZAMAR MEDICAL d.o.o.IME2026-10-12
03858894530120Shoulder Thermic WrapZAMAR MEDICAL d.o.o.IME2026-10-12
03858894530144Elbow/Wrist Thermic WrapZAMAR MEDICAL d.o.o.IME2026-10-12
03858894530168Anatomic Ankle Thermic WrapZAMAR MEDICAL d.o.o.IME2026-10-12
03858894530205Anatomic Knee Thermic WrapZAMAR MEDICAL d.o.o.IME2026-10-12
03858894530243Hip Thermic Wrap RightZAMAR MEDICAL d.o.o.IME2026-10-12
03858894530267Hip Thermic Wrap LeftZAMAR MEDICAL d.o.o.IME2026-10-12
03858894530274Jaw Thermic WrapZAMAR MEDICAL d.o.o.IME2026-10-12
03858894530281Face Thermic WrapZAMAR MEDICAL d.o.o.IME2026-10-12
03858894531257Full Leg Thermic Wrap RightZAMAR MEDICAL d.o.o.IME2026-10-12
03858894531264Full Leg Thermic Wrap LeftZAMAR MEDICAL d.o.o.IME2026-10-12
03858894531271Anatomic Knee/Thigh Thermic WrapZAMAR MEDICAL d.o.o.IME2026-10-12
00850087597029Recovery+ Go Right Shoulder Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-23
00850087597036Recovery+ Go Left Shoulder Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-23
00850087597043Recovery+ Go Cervical Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-23
00850087597050Recovery+ Go Wrist Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-23
00850087597067Recovery+ Go Ankle Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-23
00850087597074Recovery+ Go Hip Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-23
00850087597012Recovery+ Go Knee Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-17
00850087597005Recovery+ Go Lumbar Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-13
00049696508339THERA PlusFOURSTAR GROUP INC.IME2026-06-09
00049696508346B.PUREFOURSTAR GROUP INC.IME2026-06-09
00050428299838CVSHealthFOURSTAR GROUP INC.IME2026-06-09
00840295411637TherabodyTherabody, Inc.IME2026-06-01
00810178885954Arctic FlexVIVE HEALTH LLCIME2026-05-06
307073870439893M™3M COMPANYIME2026-04-21
307073870439963M™3M COMPANYIME2026-04-21
10735282287845MunchkinMUNCHKIN, INC.IME2026-03-18