Gel Foam

GUDID 00810055884162

35X80 Enmerse Gel Infused 2 way stretch Matt

JOERNS HEALTHCARE, LLC

Gel-filled bed mattress

• Primary Device ID: 00810055884162
• NIH Device Record Key: 308bf49f-0793-4721-aaac-7b8fc7050269
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gel Foam
• Version Model Number: PVEN-3580FLNA2SZP
• Company DUNS: 790937150
• Company Name: JOERNS HEALTHCARE, 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810055884162 [Primary]

FDA Product Code

• IKY: Mattress, Flotation Therapy, Non-Powered

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: 2024-04-02
• Device Publish Date: 2024-03-25

On-Brand Devices [Gel Foam]

• 00810055884209: 42X84 Enmerse Gel Infused 2 way stretch Matt
• 00810055884193: 42X80 Enmerse Gel Infused 2 way stretch Matt
• 00810055884186: 42X76 Enmerse Gel Infused 2 way stretch Matt
• 00810055884179: 35X84 Enmerse Gel Infused 2 way stretch Matt
• 00810055884162: 35X80 Enmerse Gel Infused 2 way stretch Matt
• 00810055884155: 35X76 Enmerse Gel Infused 2 way stretch Matt