Trinity Medical Devices

GUDID 00813880025595

Full Face CPAP Mask 22MM female elbow, vented Large

TRINITY MEDICAL DEVICES INC.

CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable

• Primary Device ID: 00813880025595
• NIH Device Record Key: b9eb2c92-b051-4fb9-a728-091170f10b9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trinity Medical Devices
• Version Model Number: TST102
• Company DUNS: 078728314
• Company Name: TRINITY MEDICAL DEVICES INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813880025533 [Unit of Use]
GS1	00813880025595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063268

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

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: 2018-11-15
• Device Publish Date: 2018-10-15

On-Brand Devices [Trinity Medical Devices]

• 00813880025960: All Purpose Sampling Line with T-Connector & Filter, CO2 Tub
• 00813880025953: Adult Single Port Emergency Nasal CO2 Cannula, CO2 Tube Leng
• 00813880025946: Pediatric Nasal/Oral Dual CO2 Sampling Cannula w/O2 Delivery
• 00813880025939: Adult Nasal/Oral Dual CO2 Sampling Cannula w/O2 Delivery, CO
• 00813880025922: Adult Duo Flow O2+CO2 Sampling Cannula, CO2 Tube Length: 7ft
• 00813880025915: Pediatric Nasal CO2 Sampling Cannula w/O2 Delivery, CO2 Tube
• 00813880025908: Adult Nasal CO2 Sampling Cannula w/O2 Delivery, CO2 Tube Len
• 00813880025892: Pediatric Lo-Flo Nasal/Oral CO2 Sampling Cannula, CO2 Tube L
• 00813880025885: Adult Lo-Flo Nasal/Oral CO2 Sampling Cannula, CO2 Tube Lengt
• 00813880025878: Pediatric Nasal CO2 Sampling Cannula, CO2 Tube Length: 7ft
• 00813880025861: Adult Nasal CO2 Sampling Cannula, CO2 Tube Length: 7ft
• 00813880025717: Nasal CPAP Mask 22MM female elbow, vented Large
• 00813880025700: Nasal CPAP Mask 22MM female elbow, vented Medium
• 00813880025694: Nasal CPAP Mask 22MM female elbow, vented Small
• 00813880025625: Full Face CPAP Mask 22MM female elbow, Non-vented L
• 00813880025618: Full Face CPAP Mask 22MM female elbow, Non-vented M
• 00813880025601: Full Face CPAP Mask 22MM female elbow, Non-vented S
• 00813880025595: Full Face CPAP Mask 22MM female elbow, vented Large
• 00813880025588: Full Face CPAP Mask 22MM female elbow, vented Medium
• 00813880025571: Full Face CPAP Mask 22MM female elbow, vented Small
• 00813880023508: Medication Nebulizer
• 00813880021658: 1/4 x 6 suction connection tube
• 10813880020375: 7' Oxygen Nasal Cannula Adult w/CO2 Female Luer
• 10813880020368: 7' Oxygen Nasal Cannula Adult w/CO2 Male Luer
• 00813880020132: GuedelAirwaySize10,100mm
• 00813880020125: GuedelAirwaySize9,90mm
• 00813880020118: GuedelAirwaySize8,80mm
• 00813880020101: GuedelAirwaySize7,70mm
• 00813880020095: GuedelAirwaySize6,60mm
• 00813880020088: GuedelAirwaySize5,50mm
• 00813880020071: GuedelAirwaySize4,40mm
• 00813880020064: BermanAirwaySize10,100mm
• 00813880020057: BermanAirwaySize9,90mm
• 00813880020040: BermanAirwaySize8,80mm
• 00813880020033: BermanAirwaySize7,70mm
• 00813880020026: BermanAirwaySize6,60mm
• 00813880020019: BermanAirwaySize5,50mm
• 00813880020002: BermanAirwaySize4,40mm
• 00813880025984: Neoguard Limboard, Large Std Pkg
• 00813880025977: Neoguard Limboard, Small Std Pkg
• 00813880023263: NeoGuardThermalReflectors,1.5inx1.25in
• 00813880023256: NeoGuardMiniReflectors,1inx7/8in
• 00813880025502: Ventilator Circuit
• 00813880026967: Ventilator Circuit