Nebulizer Kit

GUDID 00616784560335

DYNAREX CORPORATION

Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use

• Primary Device ID: 00616784560335
• NIH Device Record Key: fc04ab0e-f3d2-4452-8d15-8ba735029f52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nebulizer Kit
• Version Model Number: 5603
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 50
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00616784560311 [Unit of Use]
GS1	00616784560335 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Nebulizer Kit]

• 00616784560434: 5604
• 00616784560335: 5603
• 00616784560236: 5602
• 00616784560137: 5601