Resp-O2 Filter

GUDID 00840117305878

Resp-O2 Advantage Filter- Universal Respiratory B/V Filter; Adult/Ped

DYNAREX CORPORATION

Heat/moisture exchanger insertable filter
Primary Device ID00840117305878
NIH Device Record Key8a8dcfa1-ad6e-4e67-97d2-800ff3e84518
Commercial Distribution StatusIn Commercial Distribution
Brand NameResp-O2 Filter
Version Model Number30400
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 Datetrue
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117305861 [Primary]
GS100840117305878 [Package]
Contains: 00840117305861
Package: Case [50 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

Devices Manufactured by DYNAREX CORPORATION

00810180840163 - DynaSafety Cotton-Tipped Applicators in Sealed Vial,3"2024-11-19
00840117341210 - Medicine Cups 1oz 2024-11-05
00840117312906 - Resp-O2 Endotracheal Tube Cuffed, 4.0 mm 2024-11-01 Sterile-EO
00840117312920 - Resp-O2 Endotracheal Tube Cuffed, 4.5 mm 2024-11-01 Sterile-EO
00840117317475 - Resp-O2 Endotracheal Tube Cuffed, 5.0 mm 2024-11-01 Sterile-EO
00840117312968 - Resp-O2 Endotracheal Tube Cuffed, 5.5 mm 2024-11-01 Sterile-Eo
00840117312982 - Resp-O2 Endotracheal Tube Cuffed, 6.0 mm 2024-11-01 Sterile-Eo
00840117313002 - Resp-O2 Endotracheal Tube Cuffed, 6.5 mm2024-11-01 Sterile-Eo

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