Trek S

GUDID 00744229470229

Battery, Replacement, Trek S

PARI RESPIRATORY EQUIPMENT, INC.

Nebulizing system delivery set, reusable

• Primary Device ID: 00744229470229
• NIH Device Record Key: ce37214d-da5a-4649-9033-7e5d87f20d49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trek S
• Version Model Number: 047F0020
• 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	00744229100782 [Package]; Contains: 00744229470076; Package: carton [4 Units]; In Commercial Distribution
GS1	00744229470076 [Primary]
GS1	00744229470229 [Package]; Contains: 00744229470076; Package: carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060357

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: 2016-10-05

On-Brand Devices [Trek S]

• 00744229470151: PARI Trek S Replacement
• 00744229470175: PARI Trek S with DC Adapter, custom label
• 00744229470212: Adapter, multi-voltage, Trek S
• 00744229470229: Battery, Replacement, Trek S
• 00744229470182: PARI Trek S with DC Adapter
• 00744229470052: PARI Trek S Combo Pack
• 00744229470236: Port. Power Kit, TREK S
• 00744229470205: 12V DC Adapter, PARI Trek