DART-Reach

GUDID 10841470100312

PULMODYNE INC

Atomizer, non-ventilatory

• Primary Device ID: 10841470100312
• NIH Device Record Key: 6068a1a0-18b9-4962-ae14-d1d376effef1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DART-Reach
• Version Model Number: REACH600
• Company DUNS: 030619483
• Company Name: PULMODYNE 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 Dimensions

• Length: 218 Millimeter
• Length: 218 Millimeter
• Length: 218 Millimeter
• Length: 218 Millimeter
• Length: 218 Millimeter
• Length: 218 Millimeter
• Length: 218 Millimeter
• Length: 218 Millimeter
• Length: 218 Millimeter
• Length: 218 Millimeter
• Length: 218 Millimeter
• Length: 218 Millimeter
• Length: 218 Millimeter
• Length: 218 Millimeter
• Length: 218 Millimeter
• Length: 218 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470100315 [Primary]
GS1	10841470100312 [Package]; Contains: 00841470100315; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070596

FDA Product Code

• CCT: Applicator (Laryngo-Tracheal), Topical Anesthesia

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-Reach]

• 10841470100336: REACH720
• 10841470100329: REACH700
• 10841470100312: REACH600