Home GUDID 35019517101144 Portex
Primary DI 35019517101144
Brand Portex
Company Smiths Medical International Ltd
Model 8528BMP
Published 2018-07-20
Public version status New
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 BTM Ventilator, emergency, manual (resuscitator)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 35019517101144 Package GS1 9 In Commercial Distribution 15019517101140 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 35019517101144 35019517101144 15019517101140 15019517101140
GMDN Terms# Term, Definition table Term Definition Pulmonary resuscitator, manual, single-use A non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature -40 Degrees Celsius 60 Degrees Celsius
Regulatory Flags# DUNS number 215591523 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true 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 00860012073535 butterflyBVM Compact Medical Inc. BTM 2026-03-13 00860012073559 butterflyBVM, PLUS Compact Medical Inc. BTM 2026-03-13 00860012073580 butterflyBVM, READY Compact Medical Inc. BTM 2026-03-13 44710810084629 N/A GALEMED CORPORATION BTM 2026-03-05 44710810084667 N/A GALEMED CORPORATION BTM 2026-03-05 44710810085770 N/A GALEMED CORPORATION BTM 2026-03-05 44710810119116 N/A GALEMED CORPORATION BTM 2026-03-05 34026704923893 RUSCH TELEFLEX INCORPORATED BTM 2026-02-18 24026704923773 RUSCH TELEFLEX INCORPORATED BTM 2026-02-13 24026704923780 RUSCH TELEFLEX INCORPORATED BTM 2026-02-13 24026704923797 RUSCH TELEFLEX INCORPORATED BTM 2026-02-13 20885632467353 Halyard OWENS & MINOR DISTRIBUTION, INC. BTM 2026-01-29 20885632467360 Halyard OWENS & MINOR DISTRIBUTION, INC. BTM 2026-01-29 20885632467377 HALYARD OWENS & MINOR DISTRIBUTION, INC. BTM 2026-01-29 20885632490719 Halyard OWENS & MINOR DISTRIBUTION, INC. BTM 2026-01-29 20885632490740 Halyard OWENS & MINOR DISTRIBUTION, INC. BTM 2026-01-29 20885632490757 Halyard OWENS & MINOR DISTRIBUTION, INC. BTM 2026-01-29 20885632490764 Halyard OWENS & MINOR DISTRIBUTION, INC. BTM 2026-01-29 05707480152568 Ambu® SPUR® II Pediatric Resuscitator Ambu A/S BTM 2024-02-22 05707480145393 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13 05707480145416 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13 05707480145430 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13 05707480145454 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13 05707480145478 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13 05707480145492 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13 05707480145515 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13 05707480145539 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13 05707480145553 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13 05707480145577 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13 05707480145591 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13