HMEF

GUDID 10841470105478

PULMODYNE INC

Heat/moisture exchanger/microbial medical gas filter

• Primary Device ID: 10841470105478
• NIH Device Record Key: f2c3f5dd-c0b5-46df-b666-90646d0015aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HMEF
• Version Model Number: 1341902
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00841470105471 [Primary]
GS1	10841470105478 [Package]; Contains: 00841470105471; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013122

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

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: 2024-07-09
• Device Publish Date: 2024-07-01

On-Brand Devices [HMEF]

• 10841470105485: 1333002
• 10841470105478: 1341902
• 10841470105461: 1332402
• 10841470105454: 1331302