Arctic Flex

GUDID 10810113574391

Hot and Cold Wrist Wraps

VIVE HEALTH LLC

Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable

• Primary Device ID: 10810113574391
• NIH Device Record Key: 697edb88-ce07-4158-891a-8dd856ad91d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arctic Flex
• Version Model Number: RHB3013BLKPAK2
• Company DUNS: 047025993
• Company Name: VIVE HEALTH LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810113574394 [Primary]
GS1	10810113574391 [Package]; Contains: 00810113574394; Package: Case [24 Units]; In Commercial Distribution

FDA Product Code

• IME: Pack, Hot Or Cold, Reusable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-20
• Device Publish Date: 2024-03-12

On-Brand Devices [Arctic Flex ]

• 10810041987904: Knee Ice Pack
• 10810041989564: Dual Strap Ankle Ice Pack
• 10810041989410: Back and Stomach Ice Pack
• 10850041211203: Calf Ice Pack (2PK)
• 10850041211197: Calf Ice Pack
• 10818323024361: Neck Ice Pack (2 Pack)
• 10810041989427: Dual Strap Ankle Ice Pack
• 10818323028376: Gel Pack 11" x 24"
• 10850041211487: Hot/Cold Therapy Gel Sleeve Black (2XL)
• 10850041211470: Hot/Cold Therapy Gel Sleeve Black (XL)
• 10850041211463: Hot/Cold Therapy Gel Sleeve Black (Large)
• 10850041211456: Hot/Cold Therapy Gel Sleeve Black (Medium)
• 10850041211449: Hot/Cold Therapy Gel Sleeve Black (Small)
• 10810113570089: Hot/Cold Therapy Gel Sleeve Black (3XL)
• 10818323028291: Shoulder Ice Wrap Replacement Packs
• 10818323028284: Ankle Ice Wrap Replacement Packs
• 10818323028277: Knee Ice Wrap Replacement Packs
• 10810113570140: Wrist Ice Pack
• 10818323022305: Shoulder Compression Ice Wrap
• 10818323028369: Wrist Ice Wrap (Grey)
• 10810113572137: Neck Ice Pack (Large)
• 10810113570195: Hip Ice Pack
• 10810113570645: Hot/Cold Ankle Sleeve (Large)
• 10810113570638: Hot/Cold Ankle Sleeve (Medium)
• 10810113570621: Hot/Cold Ankle Sleeve (Small)
• 10810113570119: Hot/Cold Wrist Sleeve (Black) Large
• 10810113570102: Hot/Cold Wrist Sleeve (Black) Medium
• 10810113570096: Hot/Cold Wrist Sleeve (Black) Small
• 10810113572403: Hot and Cold Foot Sleeve (Large)
• 10810113572397: Hot and Cold Foot Sleeve (Medium)
• 10810113572380: Hot and Cold Foot Sleeve (Small)
• 10810113574100: Hot and Cold Back Gel Wrap
• 10810113573776: Replacement Ice Packs for Compression Ankle Ice Wrap
• 10810113574384: Hot and Cold Neck Sleeve
• 10810113574292: Hot and Cold Shoulder Sleeve (XL)
• 10810113574285: Hot and Cold Shoulder Sleeve (Standard)
• 10810041987690: LSO Ice Packs
• 10810113575008: Hot and Cold Bunion Sleeves
• 10810113574391: Hot and Cold Wrist Wraps