Portable Nebulizer

GUDID 00616784561738

DYNAREX CORPORATION

Nebulizing system, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated

• Primary Device ID: 00616784561738
• NIH Device Record Key: 29dec07d-1424-4425-9283-3645aeb11609
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Portable Nebulizer
• Version Model Number: 5617
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784561714 [Unit of Use]
GS1	00616784561738 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140237

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

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: 2019-09-17
• Device Publish Date: 2019-09-09

Devices Manufactured by DYNAREX CORPORATION

• 08401173332080 - DynaSafety Non-woven Adhesive Tape,1/2" x 2 1/2yd: 2024-07-02
• 08401173366290 - LabChoice Microscope Slides,Frosted Blue,Ground Corners: 2024-07-02 3"x 1"x1mm
• 08401173366368 - LabChoice Microscope Slides,Frosted Pink,Ground Corners: 2024-07-02 3"x1"x1mm
• 08401173366436 - LabChoice Microscope Slides,Frosted White,Ground Corner: 2024-07-02 3"x1"x1mm
• 08401173366504 - LabChoice Microscope Slides, Frosted Yellow, Ground Corner: 2024-07-02 3"x1"x1mm
• 08401173372758 - LabChoice Microscope Slides, Double Frosted, Ground Corners: 2024-07-02 3" x 1" x 1mm
• 00840117333598 - Wound Management Tray, Sterile: 2024-06-26 Contents: 1 Tray, 25 Non-woven gauze pads, 2 Cotton tip applicators, 1 Tongue depressor, 1 Bag with twist tie, 1 Towel drape.
• 00840117338012 - Debridement Kit, Sterile: 2024-06-26 Contents: 1 Cotton Tip Applicator, 1 Scalpel #11, 1 Iris Scissors, Straight, 2 Gauze Pads 4x4, 1 Adson Forceps, 1 Alcohol prep