FDA.reportPublic FDA data

Ambu® SPUR® II Pediatric Resuscitator

Primary DI
05707480150359
Brand
Ambu® SPUR® II Pediatric Resuscitator
Company
Ambu A/S
Model
530613830
Catalog number
530613830
Device description
w/CO2 Detector & Manometer
Published
2024-02-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OEVCardiopulmonary resuscitation aid kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEVCardiopulmonary Resuscitation Aid KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05707480150366PackageGS16In Commercial Distribution
05707480150359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707480150366057074801503665707480150366
05707480150359057074801503595707480150359

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation kit, single-useA collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., airway tubes, face masks, resuscitator). It is typically placed in a convenient location in public buildings and in emergency medical services (EMS) vehicles for quick access in emergency situations. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-18 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags#

DUNS number
305682023
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05707480024438Head Wedge™0002640340002640342022-12-08
05707480024476Head Wedge™0002640360002640362022-12-08
05707480024490Military Head Wedge™0002640640002640642022-12-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10194717121022Regard™ROI CPS, LLCOEV2025-02-18
10889483166291SuperNO2VAAIRLIFEOEV2025-02-14
10889483166307SuperNO2VAAIRLIFEOEV2025-02-14
10889483606025SuperNO2VAAIRLIFEOEV2025-02-14
10889483606049SuperNO2VAAIRLIFEOEV2025-02-14
10194717121039Regard™ROI CPS, LLCOEV2025-02-13
10194717121046Regard™ROI CPS, LLCOEV2025-02-13
10194717121053Regard™ROI CPS, LLCOEV2025-02-13
10194717121060Regard™ROI CPS, LLCOEV2025-02-13
10194717120971Regard™ROI CPS, LLCOEV2025-02-10
10194717120988Regard™ROI CPS, LLCOEV2025-02-10
10194717120216Regard™ROI CPS, LLCOEV2024-10-31
10194717120223Regard™ROI CPS, LLCOEV2024-10-31
10194717120254Regard™ROI CPS, LLCOEV2024-10-31
10194717120261Regard™ROI CPS, LLCOEV2024-10-31
10194717120278Regard™ROI CPS, LLCOEV2024-10-31
10194717120230Regard™ROI CPS, LLCOEV2024-10-30
10194717120247Regard™ROI CPS, LLCOEV2024-10-30
10194717120285Regard™ROI CPS, LLCOEV2024-10-30
10194717120186Regard™ROI CPS, LLCOEV2024-10-21
10194717120193Regard™ROI CPS, LLCOEV2024-10-21
10194717120209Regard™ROI CPS, LLCOEV2024-10-21
10194717120001Regard™ROI CPS, LLCOEV2024-10-02
10194717120049Regard™ROI CPS, LLCOEV2024-09-27
10194717119883Regard™ROI CPS, LLCOEV2024-08-01
10194717119876Regard™ROI CPS, LLCOEV2024-07-15
10194717119838Regard™ROI CPS, LLCOEV2024-07-05
10194717119845Regard™ROI CPS, LLCOEV2024-07-05
10194717119777Regard™ROI CPS, LLCOEV2024-06-25
10194717119784Regard™ROI CPS, LLCOEV2024-06-25