Trinity Medical Devices

GUDID 00813880025625

Full Face CPAP Mask 22MM female elbow, Non-vented L

TRINITY MEDICAL DEVICES INC.

CPAP/BPAP face mask, reusable
Primary Device ID00813880025625
NIH Device Record Keyb949b7c5-8f16-4944-9634-bc0579dddffb
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrinity Medical Devices
Version Model NumberTST105
Company DUNS078728314
Company NameTRINITY MEDICAL DEVICES INC.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100813880025564 [Unit of Use]
GS100813880025625 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-15
Device Publish Date2018-10-15

On-Brand Devices [Trinity Medical Devices]

00813880025960All Purpose Sampling Line with T-Connector & Filter, CO2 Tub
00813880025953Adult Single Port Emergency Nasal CO2 Cannula, CO2 Tube Leng
00813880025946Pediatric Nasal/Oral Dual CO2 Sampling Cannula w/O2 Delivery
00813880025939Adult Nasal/Oral Dual CO2 Sampling Cannula w/O2 Delivery, CO
00813880025922Adult Duo Flow O2+CO2 Sampling Cannula, CO2 Tube Length: 7ft
00813880025915Pediatric Nasal CO2 Sampling Cannula w/O2 Delivery, CO2 Tube
00813880025908Adult Nasal CO2 Sampling Cannula w/O2 Delivery, CO2 Tube Len
00813880025892Pediatric Lo-Flo Nasal/Oral CO2 Sampling Cannula, CO2 Tube L
00813880025885Adult Lo-Flo Nasal/Oral CO2 Sampling Cannula, CO2 Tube Lengt
00813880025878Pediatric Nasal CO2 Sampling Cannula, CO2 Tube Length: 7ft
00813880025861Adult Nasal CO2 Sampling Cannula, CO2 Tube Length: 7ft
00813880025717Nasal CPAP Mask 22MM female elbow, vented Large
00813880025700Nasal CPAP Mask 22MM female elbow, vented Medium
00813880025694Nasal CPAP Mask 22MM female elbow, vented Small
00813880025625Full Face CPAP Mask 22MM female elbow, Non-vented L
00813880025618Full Face CPAP Mask 22MM female elbow, Non-vented M
00813880025601Full Face CPAP Mask 22MM female elbow, Non-vented S
00813880025595Full Face CPAP Mask 22MM female elbow, vented Large
00813880025588Full Face CPAP Mask 22MM female elbow, vented Medium
00813880025571Full Face CPAP Mask 22MM female elbow, vented Small
00813880023508Medication Nebulizer
008138800216581/4 x 6 suction connection tube
108138800203757' Oxygen Nasal Cannula Adult w/CO2 Female Luer
108138800203687' Oxygen Nasal Cannula Adult w/CO2 Male Luer
00813880020132GuedelAirwaySize10,100mm
00813880020125GuedelAirwaySize9,90mm
00813880020118GuedelAirwaySize8,80mm
00813880020101GuedelAirwaySize7,70mm
00813880020095GuedelAirwaySize6,60mm
00813880020088GuedelAirwaySize5,50mm
00813880020071GuedelAirwaySize4,40mm
00813880020064BermanAirwaySize10,100mm
00813880020057BermanAirwaySize9,90mm
00813880020040BermanAirwaySize8,80mm
00813880020033BermanAirwaySize7,70mm
00813880020026BermanAirwaySize6,60mm
00813880020019BermanAirwaySize5,50mm
00813880020002BermanAirwaySize4,40mm
00813880025984Neoguard Limboard, Large Std Pkg
00813880025977Neoguard Limboard, Small Std Pkg
00813880023263NeoGuardThermalReflectors,1.5inx1.25in
00813880023256NeoGuardMiniReflectors,1inx7/8in
00813880025502Ventilator Circuit
00813880026967Ventilator Circuit
00813880027544Tracheal Tube UnCuffed 3.0, with Stylet
00813880027537Cuffed Endotracheal Tube 7.0
00813880027520Tracheal Tube Cuffed 5.0
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.