Wellell

GUDID 04719893353594

Optima Auto

Wellell Inc.

Alternating-pressure bed mattress system

• Primary Device ID: 04719893353594
• NIH Device Record Key: 45105e1f-2b49-4cb9-bb6d-8af98acd5f36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wellell
• Version Model Number: 9P-086020
• Company DUNS: 656413127
• Company Name: Wellell Inc.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719893353594 [Primary]

FDA Product Code

• FNM: Mattress, Air Flotation, Alternating Pressure

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: 2025-01-10
• Device Publish Date: 2025-01-02

On-Brand Devices [Wellell]

• 04719893350623: Optima Turn
• 04719893350326: Optima Turn
• 04719893350203: DOMUS Auto Pump and Mattress
• 04719893350005: DOMUS 4 Pump and Mattress
• 04719893349658: Procare Elite
• 04719893349597: DOMUS 4 Pump and Mattress
• 04719893349573: DOMUS 3 Pump and Mattress
• 04719893349498: Procare Elite
• 04719893350944: DOMUS 3 Pump and Mattress
• 04719893350869: DOMUS Auto Pump and Mattress
• 04719893352023: DOMUS 4 G2 Pump
• 04719893352535: Sedens 500
• 04719893352603: Optima Prone
• 04719893353624: Optima Auto
• 04719893353594: Optima Auto
• 04719893353549: Procare Auto G3
• 04719893353471: Procare Auto G3
• 04719893353365: Procare Auto G3
• 04719893353068: Optima Turn
• 04719893353679: Serene Air
• 04719893353860: Domus ECO
• 04719893348248: WiZARD 320 Full Face Mask(S)
• 04719893348231: WiZARD 320 Full Face Mask(M)
• 04719893348224: WiZARD 320 Full Face Mask(L)
• 04719893348026: WiZARD 310 Nasal Mask(S)
• 04719893348019: WiZARD 310 Nasal Mask(M)
• 04719893348002: WiZARD 310 Nasal Mask(L)
• 04719893354416: Procare Bariatric G2
• 04719893354386: Procare Bariatric G2
• 04719893354355: Procare Auto G2
• 04719893354652: Domus 4 Pump
• 04719893354621: Domus Auto G2
• 04719893354591: Domus 4 Pump and Mattress
• 04719893354713: Domus Auto G2
• 04719893354690: Serene Air
• 04719893354331: DOMUS 1 Pump and Mattress
• 04719893311952: DOMUS 2S Pump and Mattress
• 04719893311945: DOMUS 1 Pump and Mattress
• 04719893311884: DOMUS 4 Pump and Mattress
• 04719893311877: DOMUS Auto Pump and Mattress
• 04713025000837: WiZARD 510 Nasal Mask M Size
• 04713025000820: WiZARD 510 Nasal Mask L Size
• 04719893355574: Sedens 500
• 04719893355925: DOMUS 2S Pump and Mattress
• 04719893355901: DOMUS 1 Pump and Mattress
• 04719893355871: Domus Auto G2
• 04719893355857: Sedens 500
• 04719893355833: Sedens 500