Respo-O2 Homecare Suction Unit, Portable, Batter Operated

GUDID 00840117326576

DYNAREX CORPORATION

Emergency airway clearance suction pump, electric

• Primary Device ID: 00840117326576
• NIH Device Record Key: ae839688-97de-4998-8f51-05a24f3fdf37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Respo-O2 Homecare Suction Unit, Portable, Batter Operated
• Version Model Number: 32305
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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	00840117326576 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063448

FDA Product Code

• JCX: Apparatus, Suction, Ward Use, Portable, Ac-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: 2024-01-08
• Device Publish Date: 2023-12-29

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• 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