Kitabis

GUDID 00744229850021

Kitabis KitPak Educational Patient Kit

PARI RESPIRATORY EQUIPMENT, INC.

Nebulizing system delivery set, reusable

• Primary Device ID: 00744229850021
• NIH Device Record Key: ea5db718-8b2c-4daf-b894-348c0c365c52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kitabis
• Version Model Number: 850F0001
• 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	00744229850014 [Primary]
GS1	00744229850021 [Package]; Contains: 00744229850014; Package: carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935540

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: 2017-03-30

Devices Manufactured by PARI RESPIRATORY EQUIPMENT, INC.

• 00744229100850 - Vortex: 2024-05-08 Mask, VORTEX, Pediatric Small
• 00744229100867 - Vortex: 2024-05-08 Mask, VORTEX, Pediatric Medium
• 00744229510529 - Vortex: 2024-05-06 Vortex Nonelectrostatic Holding Chmbr
• 00744229510536 - Vortex: 2024-05-01 Vortex w Pediatric Mask Small
• 00744229510543 - Vortex: 2024-05-01 Vortex w Pediatric Mask Medium
• 00744229510512 - Vortex: 2024-05-01 Vortex Hospital Package
• 00744229510598 - Vortex: 2024-05-01 Vortex w Adult Mask
• 00744229230205 - LC Sprint Star: 2023-08-18 LC Sprint Star Neb Set