Bubbles

GUDID 00744229440840

Bubbles Pediatric Aerosol Mask

PARI RESPIRATORY EQUIPMENT, INC.

Nebulizing system delivery set, reusable

• Primary Device ID: 00744229440840
• NIH Device Record Key: 75aa6e12-cf60-42cf-9816-7b94d353396e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bubbles
• Version Model Number: 044F7254
• Company DUNS: 804736098
• Company Name: PARI RESPIRATORY EQUIPMENT, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00744229440840 [Primary]

FDA Product Code

• BYG: Mask, Oxygen

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: 2023-04-21
• Device Publish Date: 2023-04-13

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