Pediatric Compressor Nebulizer Bear

GUDID 00840117300040

DYNAREX CORPORATION

Nebulizing system, non-heated

• Primary Device ID: 00840117300040
• NIH Device Record Key: 380f9759-9879-4f22-825a-db86949b1233
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pediatric Compressor Nebulizer Bear
• Version Model Number: 5608BR
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 4
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784560823 [Unit of Use]
GS1	00840117300040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091272

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: 2019-12-03
• Device Publish Date: 2019-11-25

Devices Manufactured by DYNAREX CORPORATION

• 00616784417615 - LabChoice Microscope Cover Glass, 22 x 22 mm: 2025-02-28 Thickness: 0.12-0.17mm
• 00810180840880 - LabChoice Centrifuge Tubes, Polypropylene, Sterile, 15ML: 2025-02-28 Features: Transparent, flat caps, printed graduation, White writing area, RCF 12, 000xg. (STERILE-R)
• 00810180840903 - LabChoice Centrifuge Tubes, Polypropylene, 50 ML, Sterile: 2025-02-28 Features: Transparent, Flap Caps, Printed graduation, White Writing area, RCF 12, 000xg
• 00810180840927 - LabChoice Centrifuge Tubes, Polypropylene, 50 ML, Sterile: 2025-02-28 Features: Transparent, flap caps, printed graduation, white writing area, RCF 12, 000xg, Self-Standing
• 00810180840873 - LabChoice Centrifuge Tubes, Polypropylene: 2025-02-28 Volume: 15 mL, Material: Polypropylene, Features: Transparent, flat caps, printed graduation white writing area, RCF 12, 000xg
• 00810180840897 - LabChoice Centrifuge Tubes, Polypropylene, 50ML: 2025-02-28 Non-Sterile. Features: Transparent, flap caps, printed graduation, white writing area, RCF 12, 000xg.
• 00810180840910 - LabChoice Centrifuge Tubes, Polypropylene, 50 ML: 2025-02-28 Features: Transparent, flap caps, printed graduation, white writing area, RCF 12, 000xg, Self-Standing
• 00810180840866 - DMECare Solutions Two Button Folding Walkers, Adult, 32"-39", With 5" Wheels: 2025-02-26 Weight Capacity: 350 LB.