Home GUDID 10841470103955 O2-MAX
Primary DI 10841470103955
Brand O2-MAX
Company PULMODYNE INC
Model 313-8009-5
Published 2018-04-27
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
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 10841470103955 Package GS1 10 In Commercial Distribution 00841470103958 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 10841470103955 10841470103955 00841470103958 00841470103958 841470103958 0841470103958
GMDN Terms# Term, Definition table Term Definition Respiratory oxygen therapy system An assembly of devices designed to be interconnected to administer oxygen (O2) to a patient using various methods of oxygen administration (e.g., face mask, nasal canula) at different concentrations (e.g., via a gas mixer), duration of use, and flows. It will connect to an oxygen source and will typically include a flowmeter or flow controlling device, masks, tubing, valves, and/or nasal cannulae. It can also include, e.g., a high pressure gas reduction valve(s) and a pneumatically-powered suction device with collection bottle.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Regulatory Flags# DUNS number 030619483 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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