FDA.report

SPUR® II Adult ResuscitatorSingle Patient Use Resu

Primary DI
05707480032853
Brand
SPUR® II Adult ResuscitatorSingle Patient Use Resu
Company
Ambu A/S
Model
520212001
Catalog number
520212001
Device description
Ambu SPUR II Adult with closed reservoir, with Duraclear face mask size large adult and with PEEP valve. 12 pcs/box
Published
2016-12-19
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

Related Records

Contact Domains

Product Codes

CodeName
BTMVentilator, emergency, manual (resuscitator)

Product Code Classifications

CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707480017164PackageGS112In Commercial Distribution
05707480032853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707480017164057074800171645707480017164
05707480032853057074800328535707480032853

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 Temperature-40 Degrees Celsius60 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
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

Primary DIBrandModelCatalogPublished
05707480006397Perfit Collar™0002642010002642012022-12-08
05707480006403Perfit Collar™0002642020002642022022-12-08
05707480006410Perfit Collar™0002642030002642032022-12-08
05707480006427Perfit Collar™0002642040002642042022-12-08
05707480006434Perfit Collar™0002642050002642052022-12-08
05707480006441Perfit Collar™0002642060002642062022-12-08
05707480006458Perfit Collar™0002645010002645012022-12-08
05707480006465Perfit Collar™0002645020002645022022-12-08
05707480006472Perfit Collar™0002645030002645032022-12-08
05707480006489Perfit Collar™0002645040002645042022-12-08
05707480006496Perfit Collar™0002645050002645052022-12-08
05707480018420Perfit ACE™0002810000002810002022-12-08
05707480018437Military Perfit ACE™000281000MIL000281000MIL2022-12-08
05707480006526Mini Perfit ACE™0002811060002811062022-12-08
05707480025459AuraOnce321100000U321100000U2022-12-08
05707480025473AuraOnce321200000U321200000U2022-12-08
05707480025497AuraOnce321300000U321300000U2022-12-08
05707480025503AuraOnce321400000U321400000U2022-12-08
05707480025435AuraOnce321500000U321500000U2022-12-08
05707480025527AuraOnce321600000U321600000U2022-12-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00860012073535butterflyBVMCompact Medical Inc.BTM2026-03-13
00860012073559butterflyBVM, PLUSCompact Medical Inc.BTM2026-03-13
00860012073580butterflyBVM, READYCompact Medical Inc.BTM2026-03-13
44710810084629N/AGALEMED CORPORATIONBTM2026-03-05
44710810084667N/AGALEMED CORPORATIONBTM2026-03-05
44710810085770N/AGALEMED CORPORATIONBTM2026-03-05
44710810119116N/AGALEMED CORPORATIONBTM2026-03-05
34026704923893RUSCHTELEFLEX INCORPORATEDBTM2026-02-18
24026704923773RUSCHTELEFLEX INCORPORATEDBTM2026-02-13
24026704923780RUSCHTELEFLEX INCORPORATEDBTM2026-02-13
24026704923797RUSCHTELEFLEX INCORPORATEDBTM2026-02-13
20885632467353HalyardOWENS & MINOR DISTRIBUTION, INC.BTM2026-01-29
20885632467360HalyardOWENS & MINOR DISTRIBUTION, INC.BTM2026-01-29
20885632467377HALYARDOWENS & MINOR DISTRIBUTION, INC.BTM2026-01-29
20885632490719HalyardOWENS & MINOR DISTRIBUTION, INC.BTM2026-01-29
20885632490740HalyardOWENS & MINOR DISTRIBUTION, INC.BTM2026-01-29
20885632490757HalyardOWENS & MINOR DISTRIBUTION, INC.BTM2026-01-29
20885632490764HalyardOWENS & MINOR DISTRIBUTION, INC.BTM2026-01-29
00199972000078Curaplex®BOUND TREE MEDICAL, LLCBTM2025-12-17
30641043564602CPR-2 BagMERCURY ENTERPRISES, INC.BTM2025-12-16
44710810119628N/AGALEMED CORPORATIONBTM2025-12-01
44710810086951N/AGALEMED CORPORATIONBTM2025-11-28
30889483644540AirFlowVENTLAB, LLCBTM2025-11-25
01999720000072Curaplex®BOUND TREE MEDICAL, LLCBTM2025-11-13
00810094579593Curaplex®BOUND TREE MEDICAL, LLCBTM2025-09-24
30641043566033CPR-2 BagMERCURY ENTERPRISES, INC.BTM2025-07-15
00810094578381Curaplex®BOUND TREE MEDICAL, LLCBTM2025-07-09
00818834028714Curaplex®BOUND TREE MEDICAL, LLCBTM2025-07-09
24026704923803RUSCHTELEFLEX INCORPORATEDBTM2025-06-24
24026704923810RUSCHTELEFLEX INCORPORATEDBTM2025-06-24