DART

GUDID 10841470100282

PULMODYNE INC

Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory

• Primary Device ID: 10841470100282
• NIH Device Record Key: e9968bf5-81d7-424a-be44-32bcaa43abd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DART
• Version Model Number: DART300
• Company DUNS: 030619483
• Company Name: PULMODYNE INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00841470100285 [Primary]
GS1	10841470100282 [Package]; Contains: 00841470100285; Package: [25 Units]; In Commercial Distribution

FDA Product Code

• CCQ: Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-04
• Device Publish Date: 2022-03-25

On-Brand Devices [DART]

• 10841470100305: DART100
• 10841470100671: DART140
• 10841470100299: DART110
• 10841470100282: DART300