FDA.reportPublic FDA data

AtlanticMED

Primary DI
00860008614650
Brand
AtlanticMED
Company
Atlantic Trading LLC
Model
ATL-HCGEL-1015
Device description
RESUSABLE GEL PACK, 12 X 29 CM, 350 G, PE & NYLON
Published
2022-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
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
10860008614657PackageGS124In Commercial Distribution
00860008614650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000861465710860008614657
00860008614650008600086146508600086146500860008614650

GMDN Terms#

Term, Definition table
TermDefinition
Hot/cold therapy pack, reusableA 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) 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117485067
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008614605AtlanticMEDATL-IFW-03052022-11-09
00860008614612AtlanticMEDATL-HOT-05062022-11-09
00860008614629AtlanticMEDATL-HOT-06092022-11-09
00860008614636AtlanticMEDATL-ICE-05062022-11-09
00860008614643AtlanticMEDATL-ICE-06092022-11-09
10860008614671AtlanticMEDATL-SUR2002023-09-08
00860008614667AtlanticMEDATL-PER-06132022-11-09

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