Vortex

GUDID 00744229510512

Vortex Hospital Package

PARI RESPIRATORY EQUIPMENT, INC.

Medicine chamber spacer, reusable

• Primary Device ID: 00744229510512
• NIH Device Record Key: e0daa6f9-e7e3-4e82-a9b2-6b694945f652
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vortex
• Version Model Number: 051H8400
• Company DUNS: 804736098
• Company Name: PARI RESPIRATORY EQUIPMENT, INC.
• 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: false
• Manufacturing Date: false
• 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	00744229510505 [Primary]
GS1	00744229510512 [Package]; Contains: 00744229510505; Package: carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020944

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: 2024-05-01
• Device Publish Date: 2024-04-23

On-Brand Devices [Vortex]

• 00744229510444: Vortex Nonelectrostatic Holding Chamber, custom label
• 00744229510420: Vortex Nonelectrostatic Holding Chamber, hospital version
• 00744229510406: Vortex Nonelectrostatic Holding Chamber w/ Child mask
• 00744229510383: Vortex Nonelectrostatic holding chamber with toddler mask
• 00744229510369: Vortex Nonelectrostatic Holding Chamber
• 00744229510338: Vortex Nonelectrostatic Valved Holding Chamber, custom label
• 00744229510307: Vortex Nonelectrostatic Valved Holding Chamber w/ Child Mask
• 00744229510291: Vortex Nonelectrostatic Valved Holding Chamber w/ Toddler Mask
• 00744229510055: Vortex Nonelectrostatic Valved Holding Chamber, Hospital Pack
• 00744229510017: Vortex Nonelectrostatic Valved Holding Chamber
• 00744229100515: Mask, VORTEX, Child Frog
• 00744229100508: Mask, VORTEX, Toddler Ladybug
• 00744229100539: Mask, Vortex, Adult
• 00744229510598: Vortex w Adult Mask
• 00744229510512: Vortex Hospital Package
• 00744229510543: Vortex w Pediatric Mask Medium
• 00744229510536: Vortex w Pediatric Mask Small
• 00744229510529: Vortex Nonelectrostatic Holding Chmbr
• 00744229100867: Mask, VORTEX, Pediatric Medium
• 00744229100850: Mask, VORTEX, Pediatric Small