LC Sprint Star na

GUDID 00744229230205

LC Sprint Star Neb Set

PARI RESPIRATORY EQUIPMENT, INC.

Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable

• Primary Device ID: 00744229230205
• NIH Device Record Key: 927165bd-d6b3-427a-9479-847b225fcb68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LC Sprint Star
• Version Model Number: 023F41
• Catalog Number: na
• 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	00744229100805 [Package]; Package: carton [50 Units]; In Commercial Distribution
GS1	00744229230205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062158

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: 2023-08-18
• Device Publish Date: 2023-08-10

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: 2023-08-18LC Sprint Star Neb Set
• 00744229230205 - LC Sprint Star: 2023-08-18 LC Sprint Star Neb Set