FDA.report

Ambu® SPUR® II Adult Resuscitator

Primary DI
05707480151660
Brand
Ambu® SPUR® II Adult Resuscitator
Company
Ambu A/S
Model
520211038
Catalog number
520211038
Device description
Single Patient Use Resuscitator
Published
2024-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OEVCardiopulmonary resuscitation aid kit

Product Code Classifications

CodeDeviceSpecialtyClass
OEVCardiopulmonary Resuscitation Aid KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707480151660PackageGS112In Commercial Distribution
05707480151653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707480151660057074801516605707480151660
05707480151653057074801516535707480151653

GMDN Terms

TermDefinition
Pulmonary resuscitator, manual, single-useA 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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature-18 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+14107686464Purchase_orders@ambuUSA.com
+1(410)768-6464Purchase_orders@ambuUSA.com

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
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

Primary DIBrandModelCatalogPublished
05707480135363SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator5206111015206111012017-10-13
05707480135585SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator5236310115236310112018-07-09
05707480135615SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator5306390115306390112017-10-13
05707480136018SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator5442160475442160472018-05-28
05707480145294SPUR® II Adult Resuscitator5246140005246140002020-06-24
05707480145317SPUR® II Pediatric Resuscitator5316160005316160002020-06-24
05707480145348SPUR® II Adult Resuscitator5206110745206110742020-06-24
05707480145393SPUR® II Adult Resuscitator520211000BE520211000BE2021-04-13
05707480145416SPUR® II Adult Resuscitator520211000E520211000E2021-04-13
05707480145430SPUR® II Adult Resuscitator520211001E520211001E2021-04-13
05707480145454SPUR® II Adult Resuscitator520211010E520211010E2021-04-13
05707480145478SPUR® II Adult Resuscitator520214000E520214000E2021-04-13
05707480145492SPUR® II Adult Resuscitator520611000E520611000E2021-04-13
05707480145515SPUR® II Adult Resuscitator521611000E521611000E2021-04-13
05707480145539SPUR® II Adult Resuscitator523211000E523211000E2021-04-13
05707480145553SPUR® II Adult Resuscitator523211001E523211001E2021-04-13
05707480145577SPUR® II Adult Resuscitator523611030E523611030E2021-04-13
05707480145591SPUR® II Adult Resuscitator523611031E523611031E2021-04-13
05707480027354SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator5232110005232110002016-12-19
05707480027361SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator5232110015232110012016-12-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05707480162925SPUR® II Infant ResuscitatorAmbu A/SOEV2025-06-06
20194717121029Regard™ROI CPS, LLCOEV2025-02-18
30889483166295SuperNO2VASunmed Group Holdings, LLCOEV2025-02-14
30889483166301SuperNO2VASunmed Group Holdings, LLCOEV2025-02-14
30889483606029SuperNO2VASunmed Group Holdings, LLCOEV2025-02-14
30889483606043SuperNO2VASunmed Group Holdings, LLCOEV2025-02-14
20194717121036Regard™ROI CPS, LLCOEV2025-02-13
20194717121043Regard™ROI CPS, LLCOEV2025-02-13
20194717121050Regard™ROI CPS, LLCOEV2025-02-13
20194717121067Regard™ROI CPS, LLCOEV2025-02-13
20194717120978Regard™ROI CPS, LLCOEV2025-02-10
20194717120985Regard™ROI CPS, LLCOEV2025-02-10
20194717120213Regard™ROI CPS, LLCOEV2024-10-31
20194717120220Regard™ROI CPS, LLCOEV2024-10-31
20194717120251Regard™ROI CPS, LLCOEV2024-10-31
20194717120268Regard™ROI CPS, LLCOEV2024-10-31
20194717120275Regard™ROI CPS, LLCOEV2024-10-31
20194717120237Regard™ROI CPS, LLCOEV2024-10-30
20194717120244Regard™ROI CPS, LLCOEV2024-10-30
20194717120282Regard™ROI CPS, LLCOEV2024-10-30
20194717120183Regard™ROI CPS, LLCOEV2024-10-21
20194717120190Regard™ROI CPS, LLCOEV2024-10-21
20194717120206Regard™ROI CPS, LLCOEV2024-10-21
20194717120008Regard™ROI CPS, LLCOEV2024-10-02
20194717120046Regard™ROI CPS, LLCOEV2024-09-27
20194717119880Regard™ROI CPS, LLCOEV2024-08-01
20194717119873Regard™ROI CPS, LLCOEV2024-07-15
20194717119835Regard™ROI CPS, LLCOEV2024-07-05
20194717119842Regard™ROI CPS, LLCOEV2024-07-05
20194717119774Regard™ROI CPS, LLCOEV2024-06-25