Resp-O2 Heat Moisture Exchanger

GUDID 00840117318083

Resp-O2 Heat Moisture Exchanger (HME) 1500, Integrated Flex Tube; Adult/Ped

DYNAREX CORPORATION

Heat/moisture exchanger, single-use

• Primary Device ID: 00840117318083
• NIH Device Record Key: 095bff03-e8f3-4fd7-b87b-9f7f101145fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Heat Moisture Exchanger
• Version Model Number: 30202
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00840117318083 [Package]; Contains: 00840117318090; Package: Case [50 Units]; In Commercial Distribution
GS1	00840117318090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132709

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: 2021-04-30
• Device Publish Date: 2021-04-22

On-Brand Devices [Resp-O2 Heat Moisture Exchanger]

• 00840117318120: Resp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy, Bow Tie; Adult
• 00840117318106: Resp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy T-Shape with Swivel Oxygen Port; Adult
• 00840117318083: Resp-O2 Heat Moisture Exchanger (HME) 1500, Integrated Flex Tube; Adult/Ped
• 00840117305892: Heat Moisture Exchanger (HME) Tracheostomy w/ side oxygen port; adult/ped
• 00840117305649: Resp-O2 Tracheostomy Pediatric Flex Connector 15mmODx 15mm ID
• 00840117305625: Resp-O2 Tracheostomy Adult Flex Connector 15mmOD x 22mmOD/15mmID
• 00840117305601: Resp-O2 Universal 6" Flex Tube, Adult, Connector 12F/22F
• 00840117305588: (HEPA) Filter w/ CO2 Port
• 00840117305564: Resp-O2 Heat Moisture Exchanger (HME) 1250 Tracheostomy T-Shape w/Suction Port & Front Oxygen Po
• 00840117305502: Resp-O2 Pediatric/Neonatal Mini Tracheostomy (HME)
• 00840117305489: Resp-O2 Heat Moisture Exchanger (HME) 600, HCH, CO2 Port, Pediatric
• 00840117305465: Resp-O2 Heat Moisture Exchanger (HME) 1500, HCH, CO2 Port, Flex Tube, Adult
• 00840117305441: Resp-O2 Heat Moisture Exchanger (HME) 1500, Adult, HCH, CO2 Port
• 00840117305427: Heat Moisture Exchanger (HME) 150, Adult
• 00840117305403: Resp-O2 Heat Moisture Exchanger (HMEF) 1500 and HEPA Filter, CO2 Port
• 00840117305380: Resp-O2 Hygroscopic Condenser Humidifier (HMEF) 600 B/V Filter, CO2 Port, Pediatric
• 00840117305366: Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500 B/V Filter, CO2 Port and Flex Tube, Adult
• 00840117305342: Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500 B/V Filter and CO2 Port, Adult
• 00840117305328: Resp-O2 Heat Moisture Exchanger & B/V Filter (HMEF) 1000 CO2 Port, Low Profile, Adult
• 00840117305304: Resp-O2 Heat Moisture Exchanger & B/V Filter (HMEF) 1000, CO2 Port and Flex Tube, Low Profile, A
• 00840117305281: Resp-O2 Heat Moisture Exchanger (HMEF) 1000 B/V CO2 Flex Tube, Adult