Resp-O2 Heat Moisture Exchanger

GUDID 00840117305342

Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500 B/V Filter and CO2 Port, Adult

DYNAREX CORPORATION

Heat/moisture exchanger/microbial filter, non-sterile
Primary Device ID00840117305342
NIH Device Record Key5c944452-1235-4327-a1e5-ca609b33885e
Commercial Distribution StatusIn Commercial Distribution
Brand NameResp-O2 Heat Moisture Exchanger
Version Model Number30105
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117305335 [Primary]
GS100840117305342 [Package]
Contains: 00840117305335
Package: Case [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAHFilter, Bacterial, Breathing-Circuit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-30
Device Publish Date2021-04-22

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

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.