HMEF W/Luer lock port (Dead space 45ml)

GUDID 14716770703029

HMEF W/Luer lock port (Dead space 45ml)

BESMED HEALTH BUSINESS CORP.

Heat/moisture exchanger/microbial medical gas filter

• Primary Device ID: 14716770703029
• NIH Device Record Key: 84bef827-ca26-47bb-9681-d64d41efac17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HMEF W/Luer lock port (Dead space 45ml)
• Version Model Number: FL-70302
• Company DUNS: 658023775
• Company Name: BESMED HEALTH BUSINESS CORP.
• 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: true
• 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	04716770703022 [Primary]
GS1	14716770703029 [Package]; Contains: 04716770703022; Package: Carton box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241339

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: 2026-02-19
• Device Publish Date: 2026-02-11

Devices Manufactured by BESMED HEALTH BUSINESS CORP.

• 04716770701127 - HME W/Luer lock port (Dead space 45ml): 2026-02-19 HME W/Luer lock port (Dead space 45ml)
• 04716770701158 - Angled HME with luer lock port: 2026-02-19 Angled HME with luer lock port
• 04716770702230 - Bacterial Filter (Dead space 32ml): 2026-02-19 Bacterial Filter (Dead space 32ml)
• 14716770703029 - HMEF W/Luer lock port (Dead space 45ml): 2026-02-19HMEF W/Luer lock port (Dead space 45ml)
• 14716770703029 - HMEF W/Luer lock port (Dead space 45ml): 2026-02-19 HMEF W/Luer lock port (Dead space 45ml)
• 14716770703036 - HMEF W/Luer lock port (Dead space 60ml): 2026-02-19 HMEF W/Luer lock port (Dead space 60ml)
• 14716770703067 - HMEF (Dead space 60ml): 2026-02-19 HMEF (Dead space 60ml)
• 04716770834221 - ICU gas sampling pack: 2022-08-16 OEM ref: C05096-01-11
• 04716770834238 - ICU gas sampling pack with flowmeter: 2022-08-16 OEM ref: C05096-02-11