Home GUDID 00812277036862 Curaplex
Primary DI 00812277036862
Brand Curaplex
Company BOUND TREE MEDICAL, LLC
Model 8600-01468
Catalog number 8600-01468
Device description *Custom* Curaplex CPAP Capno Filter Kit
Published 2020-11-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name BYE Attachment, breathing, positive end expiratory pressure
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00812277036862 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00812277036862 00812277036862 812277036862 0812277036862
GMDN Terms# Term, Definition table Term Definition CPAP/BPAP nasal mask, single-use A non-sterile, flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
Regulatory Flags# DUNS number 070556204 Device count 1 DM exempt true Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810094578534 Curaplex® BOUND TREE MEDICAL, LLC BYE 2025-08-06 00810094578008 Curaplex® BOUND TREE MEDICAL, LLC BYE 2025-07-09 00810094578015 Curaplex® BOUND TREE MEDICAL, LLC BYE 2025-07-09 00810094578022 Curaplex® BOUND TREE MEDICAL, LLC BYE 2025-07-09 00810094578039 Curaplex® BOUND TREE MEDICAL, LLC BYE 2025-07-09 00810094578046 Curaplex® BOUND TREE MEDICAL, LLC BYE 2025-07-09 00026072001479 EM Allied Medical, LLC BYE 2024-05-28 00810094574987 Curaplex BOUND TREE MEDICAL, LLC BYE 2023-02-28 00810094575007 Curaplex BOUND TREE MEDICAL, LLC BYE 2023-02-28 00810094574994 Curaplex BOUND TREE MEDICAL, LLC BYE 2023-02-28 00810094575014 Curaplex BOUND TREE MEDICAL, LLC BYE 2023-02-28 10884521831643 Shiley Covidien LP BYE 2023-02-18 10884521831636 Shiley Covidien LP BYE 2023-02-16 00810071637261 Curaplex BOUND TREE MEDICAL, LLC BYE 2022-12-30 00810071637278 Curaplex BOUND TREE MEDICAL, LLC BYE 2022-12-30 00709078013560 Bracket with Tube Guide WESTMED, INC. BYE 2021-10-15 00709078013546 WaterPAP Pole Clamp WESTMED, INC. BYE 2021-10-08 00709078013607 WaterPAP™ Starter Kit WESTMED, INC. BYE 2021-10-08 00709078013621 WaterPAP™ Pro Starter Kit WESTMED, INC. BYE 2021-10-08 00709078013195 WaterPAP WESTMED, INC. BYE 2021-08-31 10641043574041 Flow-Safe II+ BiLevel Disposable CPAP System MERCURY ENTERPRISES, INC. BYE 2021-01-14 10641043574058 Flow-Safe II+ BiLevel Disposable CPAP System MERCURY ENTERPRISES, INC. BYE 2021-01-14 10641043572443 Flow-Safe II Disposable CPAP System MERCURY ENTERPRISES, INC. BYE 2020-11-12 10641043572450 Flow-Safe II Disposable CPAP System MERCURY ENTERPRISES, INC. BYE 2020-11-12 10641043572467 Flow-Safe II Disposable CPAP System MERCURY ENTERPRISES, INC. BYE 2020-11-12 08498840012130 VYGON Vygon Corporation BYE 2020-03-12 15019315061066 Portex ICU MEDICAL, INC. BYE 2020-03-12 15019315061073 Portex ICU MEDICAL, INC. BYE 2020-03-12 15019315061080 Portex ICU MEDICAL, INC. BYE 2020-03-12 10190752133181 AirLife™ AIRLIFE BYE 2020-01-15