LC Plus

GUDID 00744229100140

Baby Neb Set, Sz 1

PARI RESPIRATORY EQUIPMENT, INC.

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

• Primary Device ID: 00744229100140
• NIH Device Record Key: 4597c55b-e823-4b5f-a09f-539c50c148f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LC Plus
• Version Model Number: 022F91
• 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	00744229100140 [Package]; Contains: 00744229220374; Package: carton [12 Units]; In Commercial Distribution
GS1	00744229220374 [Primary]

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: 2016-09-30

On-Brand Devices [LC Plus]

• 00744229100041: Mouthpiece, LC Plus
• 00744229100102: Nebulizer Kit, LC Plus, Vios Pro
• 00744229100126: Nebulizer Kit, LC Plus, Retail custom
• 00744229100034: Mouthpiece, LC Plus
• 00744229100119: Nebulizer Kit, LC Plus, custom label
• 00744229100089: LC Plus Neb Set, Ped. Mask
• 00744229100072: LC Plus Neb Set, Adult Mask
• 00744229100157: Baby Neb Set, Sz 2
• 00744229100140: Baby Neb Set, Sz 1
• 00744229100133: Baby Neb Set, Sz 0
• 00744229100096: LC Plus Neb Set
• 00744229100720: PARI LC Plus, Nebulizer Set, PRO