Revanesse Gel Pack

GUDID 10669808005791

Reusable cold pack.

Prollenium Medical

Musculoskeletal hot/cold therapy pack, reusable

• Primary Device ID: 10669808005791
• NIH Device Record Key: 004422e8-0f3b-48f6-811a-5ab627dc68d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revanesse Gel Pack
• Version Model Number: PN99802
• Company DUNS: 247326606
• Company Name: Prollenium Medical
• Device Count: 1
• DM Exempt: false
• 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: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10669808005791 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-01-12
• Device Publish Date: 2025-05-22

Devices Manufactured by Prollenium Medical

• 10669808005791 - Revanesse Gel Pack: 2026-01-12Reusable cold pack.
• 10669808005791 - Revanesse Gel Pack: 2026-01-12 Reusable cold pack.
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