ThermoFlo®

GUDID 10810050855669

CircuitGuard ThermoFlo 1 Filter - Combined HME, Bacterial Viral Filter w O2 Port (Kung Shin)

TYPENEX MEDICAL LLC

Heat/moisture exchanger/microbial medical gas filter

• Primary Device ID: 10810050855669
• NIH Device Record Key: 0b5c01a7-9935-4569-8c68-7252801d7867
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermoFlo®
• Version Model Number: 6001
• Company DUNS: 600850213
• Company Name: TYPENEX MEDICAL LLC
• 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: false
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810050855662 [Primary]
GS1	10810050855669 [Package]; Contains: 00810050855662; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032878

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: 2024-11-28
• Device Publish Date: 2024-11-20

On-Brand Devices [ThermoFlo®]

• 10810050853764: ThermoFlo ® 1 – Heat Moisture Exchanger
• 00810050853712: ThermoFlo® Trach Basic with O2 Port and Suction Port
• 10810050853702: ThermoFlo® Trach Basic
• 10810050853696: ThermoFlo ® 1 – Heat Moisture Exchanger
• 10810050852200: ThermoFlo® Filter – Combined Heat Moisture Exchanger / Bacterial Viral Filter
• 10810050853900: ThermoFlo Heat Moisture Exchanger
• 10810050853887: ThermoFlo Neo
• 10810050853726: ThermoFlo® Trach with Suction Port
• 00810050855624: ThermoFlo® Neo, Heat and Moisture Condenser for Neonatal
• 10810050855669: CircuitGuard ThermoFlo 1 Filter - Combined HME, Bacterial Viral Filter w O2 Port (Kung Shin)
• 00810050855631: ThermoFlo Trach, Heat and Moisture Condenser - Manufactured By Ningbo Boya