Air Mattress, Deluxe Digital, Cell on Cell, 48" Bariatric

GUDID 00616784044613

DYNAREX CORPORATION

Alternating-pressure bed mattress system

• Primary Device ID: 00616784044613
• NIH Device Record Key: 0ac3f7ec-49b1-4fa3-bc0b-556de04250c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Air Mattress, Deluxe Digital, Cell on Cell, 48" Bariatric
• Version Model Number: 10446
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• 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: false
• Manufacturing Date: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784044613 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-09-04
• Device Publish Date: 2018-05-23

Devices Manufactured by DYNAREX CORPORATION

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• 00616784704210 - IV Administration Sets, 10 mL, Non-Toxic: 2025-08-11 Sterile-EO
• 00616784704418 - IV Administration Set, 20 mL, Non-Toxic: 2025-08-11 Sterile-EO
• 00616784304113 - Dmecare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 16"x16". Weight Capacity: 300 LB.
• 00616784304212 - DMECare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 18"x 16". Weight Capacity: 300 LB
• 00616784304311 - DMECare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 20" x 16". Weight Capacity: 300 LB
• 00616784304410 - DMECare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 22" x 18" Weight Capacity: 300 LB
• 00616784304519 - DMECare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 24" x 18". Weight Capacity: 300 LB