Saline

GUDID 00744229307129

7% Hypertonic Saline

PARI RESPIRATORY EQUIPMENT, INC.

Inhalation therapy saline solution, hypertonic Inhalation therapy saline solution, hypertonic

• Primary Device ID: 00744229307129
• NIH Device Record Key: 051941c8-709c-4ec4-9026-8725af4c774e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Saline
• Version Model Number: 300F7010
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00744229307129 [Package]; Contains: 00744229307600; Package: carton [12 Units]; In Commercial Distribution
GS1	00744229307600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070498

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-17

Devices Manufactured by PARI RESPIRATORY EQUIPMENT, INC.

• 00744229230205 - LC Sprint Star: 2023-08-18 LC Sprint Star Neb Set
• 00744229440703 - Wing Tip: 2023-07-06 Tubing, Wing Tip, Safety Core
• 00744229100706 - Proneb Max: 2023-06-29 Proneb Max, 5 Yr, LC Sprint
• 00744229440840 - Bubbles: 2023-04-21 Bubbles Pediatric Aerosol Mask
• 00744229130062 - Proneb Max: 2020-08-03 Replacement Filter, Proneb Max
• 00744229100720 - LC Plus: 2020-04-15 PARI LC Plus, Nebulizer Set, PRO
• 00744229100737 - LC Sprint: 2020-04-15 PARI LC Sprint, Nebulizer Set, PRO
• 00744229100676 - Lamira: 2019-02-08 Lamira Nebulizer System