CLEAR-THERM MICRO HMEF L/PORT

GUDID 05030267038312

CLEAR-THERM MICRO HMEF L/PORT

INTERSURGICAL INCORPORATED

Heat/moisture exchanger/microbial filter, non-sterile

• Primary Device ID: 05030267038312
• NIH Device Record Key: 70966b34-6e6e-4c0d-8864-8f909a55456c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEAR-THERM MICRO HMEF L/PORT
• Version Model Number: 1441000
• Company DUNS: 785952607
• Company Name: INTERSURGICAL INCORPORATED
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05030267038305 [Package]; Package: [80 Units]; In Commercial Distribution
GS1	05030267038312 [Package]; Contains: 05030267052523; Package: [20 Units]; In Commercial Distribution
GS1	05030267052523 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032322

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: 2021-10-12
• Device Publish Date: 2021-10-04

Devices Manufactured by INTERSURGICAL INCORPORATED

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• 05030267045884 - 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M: 2025-04-24 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M
• 05030267001804 - TRACHEOSTOMY MASK, PAEDIATRIC: 2025-04-23 TRACHEOSTOMY MASK, PAEDIATRIC
• 05030267098088 - PREMATURE, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.1M: 2025-04-23 PREMATURE, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.1M
• 05030267165285 - 22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVE: 2025-04-23 22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVEL ELBOW. 1.6M
• 00816472022552 - Nose Clip with Padding: 2025-04-22 Nose Clip with Padding
• 05030267161546 - 22mm Compact breathing system: 2025-04-22 22mm Compact breathing system with 3L bag, elbow, monitoring line, anesthetic face mask and HMEF >3m
• 05030267161751 - 22mm Compact breathing system: 2025-04-22 22mm Compact breathing system with 3L bag, monitoring line, HMEF, and Clearlite facemask >3 m