Altera

GUDID 00744229678311

Altera Nebulizer Handset

PARI RESPIRATORY EQUIPMENT, INC.

Ultrasonic nebulizing system

• Primary Device ID: 00744229678311
• NIH Device Record Key: 5345dc92-7a14-457c-a031-488be70812cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Altera
• Version Model Number: 678G8000
• 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: false
• Serial Number: true
• 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	00744229678052 [Primary]
GS1	00744229678311 [Package]; Contains: 00744229678052; Package: carton [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100380

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: 2016-09-26

On-Brand Devices [Altera]

• 00744229789024: Medication Cap (N) & Cap Seal, Gray
• 00744229678229: eBase Controller with Connection Cord
• 00744229678090: eBase Controller, Altera
• 00744229678311: Altera Nebulizer Handset
• 00744229678304: Altera Nebulizer System
• 00744229178026: Nebulizer Connection Cord