ThermoFlo®

GUDID 00810050855624

ThermoFlo® Neo, Heat and Moisture Condenser for Neonatal

TYPENEX MEDICAL LLC

Anaesthesia breathing circuit, single-use

• Primary Device ID: 00810050855624
• NIH Device Record Key: 1d994c08-5be2-48e9-aaa0-99557ff00c87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermoFlo®
• Version Model Number: 6215
• Company DUNS: 600850213
• Company Name: TYPENEX MEDICAL LLC
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810050855600 [Primary]
GS1	00810050855624 [Unit of Use]
GS1	10810050855621 [Primary]

FDA Product Code

• BYD: Condenser, Heat And Moisture (Artificial Nose)

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: 2024-11-22
• Device Publish Date: 2024-11-14

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