LC Star

GUDID 00744229100058

LC Star nebulizer set

PARI RESPIRATORY EQUIPMENT, INC.

Nebulizing system delivery set, reusable

• Primary Device ID: 00744229100058
• NIH Device Record Key: 0a8357a6-02d4-4cb4-9752-8f980c13be9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LC Star
• Version Model Number: 022F51
• 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	00744229100058 [Package]; Contains: 00744229220824; Package: carton [12 Units]; In Commercial Distribution
GS1	00744229220824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963924

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

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