Home GUDID 00810113578811 Arctic Flex
Primary DI 00810113578811
Brand Arctic Flex
Company VIVE HEALTH LLC
Model RHB3038UNI
Device description Elbow Ice Pack
Published 2025-08-25
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 Code Name IME Pack, Hot Or Cold, Reusable
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IME Pack, Hot Or Cold, Reusable Physical Medicine 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810113578811 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810113578811 00810113578811 810113578811 0810113578811
GMDN Terms# Term, Definition table Term Definition Hot/cold therapy pack, reusable A 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.
Regulatory Flags# DUNS number 047025993 Device count 1 DM exempt true Premarket exempt true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 03858894530069 Thigh Thermic Wrap ZAMAR MEDICAL d.o.o. IME 2026-10-12 03858894530083 Knee/Calf Thermic Wrap ZAMAR MEDICAL d.o.o. IME 2026-10-12 03858894530106 Lumbar Thermic Wrap ZAMAR MEDICAL d.o.o. IME 2026-10-12 03858894530120 Shoulder Thermic Wrap ZAMAR MEDICAL d.o.o. IME 2026-10-12 03858894530144 Elbow/Wrist Thermic Wrap ZAMAR MEDICAL d.o.o. IME 2026-10-12 03858894530168 Anatomic Ankle Thermic Wrap ZAMAR MEDICAL d.o.o. IME 2026-10-12 03858894530205 Anatomic Knee Thermic Wrap ZAMAR MEDICAL d.o.o. IME 2026-10-12 03858894530243 Hip Thermic Wrap Right ZAMAR MEDICAL d.o.o. IME 2026-10-12 03858894530267 Hip Thermic Wrap Left ZAMAR MEDICAL d.o.o. IME 2026-10-12 03858894530274 Jaw Thermic Wrap ZAMAR MEDICAL d.o.o. IME 2026-10-12 03858894530281 Face Thermic Wrap ZAMAR MEDICAL d.o.o. IME 2026-10-12 03858894531257 Full Leg Thermic Wrap Right ZAMAR MEDICAL d.o.o. IME 2026-10-12 03858894531264 Full Leg Thermic Wrap Left ZAMAR MEDICAL d.o.o. IME 2026-10-12 03858894531271 Anatomic Knee/Thigh Thermic Wrap ZAMAR MEDICAL d.o.o. IME 2026-10-12 00850087597029 Recovery+ Go Right Shoulder Thermal Compression Wrap WMI ENTERPRISES, LLC IME 2026-07-23 00850087597036 Recovery+ Go Left Shoulder Thermal Compression Wrap WMI ENTERPRISES, LLC IME 2026-07-23 00850087597043 Recovery+ Go Cervical Thermal Compression Wrap WMI ENTERPRISES, LLC IME 2026-07-23 00850087597050 Recovery+ Go Wrist Thermal Compression Wrap WMI ENTERPRISES, LLC IME 2026-07-23 00850087597067 Recovery+ Go Ankle Thermal Compression Wrap WMI ENTERPRISES, LLC IME 2026-07-23 00850087597074 Recovery+ Go Hip Thermal Compression Wrap WMI ENTERPRISES, LLC IME 2026-07-23 00850087597012 Recovery+ Go Knee Thermal Compression Wrap WMI ENTERPRISES, LLC IME 2026-07-17 00850087597005 Recovery+ Go Lumbar Thermal Compression Wrap WMI ENTERPRISES, LLC IME 2026-07-13 00049696508339 THERA Plus FOURSTAR GROUP INC. IME 2026-06-09 00049696508346 B.PURE FOURSTAR GROUP INC. IME 2026-06-09 00050428299838 CVSHealth FOURSTAR GROUP INC. IME 2026-06-09 00840295411637 Therabody Therabody, Inc. IME 2026-06-01 00810178885954 Arctic Flex VIVE HEALTH LLC IME 2026-05-06 30707387043989 3M™ 3M COMPANY IME 2026-04-21 30707387043996 3M™ 3M COMPANY IME 2026-04-21 10735282287845 Munchkin MUNCHKIN, INC. IME 2026-03-18