Home GUDID 05707480153725 Ambu® SPUR® II Adult Resuscitator
Primary DI 05707480153725
Brand Ambu® SPUR® II Adult Resuscitator
Company Ambu A/S
Model 523211000E
Catalog number 523211000E
Device description Single Patient Use Resuscitator
Published 2024-02-15
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name OEV Cardiopulmonary resuscitation aid kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OEV Cardiopulmonary Resuscitation Aid Kit Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05707480153725 Package GS1 12 In Commercial Distribution 05707480153718 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05707480153725 05707480153725 5707480153725 05707480153718 05707480153718 5707480153718
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 -18 Degrees Celsius 50 Degrees Celsius Storage Environment Temperature 15 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 305682023 Device count 1 DM exempt false Premarket exempt true 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 false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05707480135363 SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520611101 520611101 2017-10-13 05707480135585 SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 523631011 523631011 2018-07-09 05707480135615 SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530639011 530639011 2017-10-13 05707480136018 SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 544216047 544216047 2018-05-28 05707480145294 SPUR® II Adult Resuscitator 524614000 524614000 2020-06-24 05707480145317 SPUR® II Pediatric Resuscitator 531616000 531616000 2020-06-24 05707480145348 SPUR® II Adult Resuscitator 520611074 520611074 2020-06-24 05707480145393 SPUR® II Adult Resuscitator 520211000BE 520211000BE 2021-04-13 05707480145416 SPUR® II Adult Resuscitator 520211000E 520211000E 2021-04-13 05707480145430 SPUR® II Adult Resuscitator 520211001E 520211001E 2021-04-13 05707480145454 SPUR® II Adult Resuscitator 520211010E 520211010E 2021-04-13 05707480145478 SPUR® II Adult Resuscitator 520214000E 520214000E 2021-04-13 05707480145492 SPUR® II Adult Resuscitator 520611000E 520611000E 2021-04-13 05707480145515 SPUR® II Adult Resuscitator 521611000E 521611000E 2021-04-13 05707480145539 SPUR® II Adult Resuscitator 523211000E 523211000E 2021-04-13 05707480145553 SPUR® II Adult Resuscitator 523211001E 523211001E 2021-04-13 05707480145577 SPUR® II Adult Resuscitator 523611030E 523611030E 2021-04-13 05707480145591 SPUR® II Adult Resuscitator 523611031E 523611031E 2021-04-13 05707480027354 SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 523211000 523211000 2016-12-19 05707480027361 SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 523211001 523211001 2016-12-19
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05707480162925 SPUR® II Infant Resuscitator Ambu A/S OEV 2025-06-06 20194717121029 Regard™ ROI CPS, LLC OEV 2025-02-18 30889483166295 SuperNO2VA Sunmed Group Holdings, LLC OEV 2025-02-14 30889483166301 SuperNO2VA Sunmed Group Holdings, LLC OEV 2025-02-14 30889483606029 SuperNO2VA Sunmed Group Holdings, LLC OEV 2025-02-14 30889483606043 SuperNO2VA Sunmed Group Holdings, LLC OEV 2025-02-14 20194717121036 Regard™ ROI CPS, LLC OEV 2025-02-13 20194717121043 Regard™ ROI CPS, LLC OEV 2025-02-13 20194717121050 Regard™ ROI CPS, LLC OEV 2025-02-13 20194717121067 Regard™ ROI CPS, LLC OEV 2025-02-13 20194717120978 Regard™ ROI CPS, LLC OEV 2025-02-10 20194717120985 Regard™ ROI CPS, LLC OEV 2025-02-10 20194717120213 Regard™ ROI CPS, LLC OEV 2024-10-31 20194717120220 Regard™ ROI CPS, LLC OEV 2024-10-31 20194717120251 Regard™ ROI CPS, LLC OEV 2024-10-31 20194717120268 Regard™ ROI CPS, LLC OEV 2024-10-31 20194717120275 Regard™ ROI CPS, LLC OEV 2024-10-31 20194717120237 Regard™ ROI CPS, LLC OEV 2024-10-30 20194717120244 Regard™ ROI CPS, LLC OEV 2024-10-30 20194717120282 Regard™ ROI CPS, LLC OEV 2024-10-30 20194717120183 Regard™ ROI CPS, LLC OEV 2024-10-21 20194717120190 Regard™ ROI CPS, LLC OEV 2024-10-21 20194717120206 Regard™ ROI CPS, LLC OEV 2024-10-21 20194717120008 Regard™ ROI CPS, LLC OEV 2024-10-02 20194717120046 Regard™ ROI CPS, LLC OEV 2024-09-27 20194717119880 Regard™ ROI CPS, LLC OEV 2024-08-01 20194717119873 Regard™ ROI CPS, LLC OEV 2024-07-15 20194717119835 Regard™ ROI CPS, LLC OEV 2024-07-05 20194717119842 Regard™ ROI CPS, LLC OEV 2024-07-05 20194717119774 Regard™ ROI CPS, LLC OEV 2024-06-25
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