FDA.reportPublic FDA data

Ambu® ACTion™ Block Pump

Primary DI
05707480155767
Brand
Ambu® ACTion™ Block Pump
Company
Ambu A/S
Model
419150650C
Catalog number
419150650C
Device description
Action Block, MBII, 650 mL, 1-6 mL/hr Regulator
Published
2022-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEBPump, infusion, elastomeric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEBPump, Infusion, ElastomericGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131247000MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEMMfs - Medical Flow Systems, Ltd.2013-08-14MEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05707480155750PackageGS14In Commercial Distribution
05707480155767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707480155750057074801557505707480155750
05707480155767057074801557675707480155767

GMDN Terms#

Term, Definition table
TermDefinition
Elastomeric infusion pump kitA collection of sterile devices designed to enable a healthcare provider or patient to perform infusion therapy using an elastomeric infusion pump. The kit typically consists of the infusion pump and other devices such as a catheter, tunneller, needle, sheath, syringe, dressings, adhesive strips, and a filling device for the infusion pump. This device is typically used for the infusion of fluids, antibiotics, chemotherapeutic agents, or pain management medications in the healthcare facility or the home. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume650Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-15 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+14107686464Purchase_orders@ambuUSA.com

Regulatory Flags#

DUNS number
305682023
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05707480024650Ambu® Mini Perfit ACE™0002811060002811062022-12-08
05707480024674Ambu® Immobilization Kit, with0002811610002811612022-12-08
05707480026197BlueSensor NEOXECG ElectrodesNEOX-60-K/US/3NEOX-60-K/US/32016-09-21
05707480024513Ambu® Perfit Collar™0002642010002642012022-12-08
05707480024520Ambu® Perfit Collar™0002642020002642022022-12-08
05707480024537Ambu® Perfit Collar™0002642030002642032022-12-08
05707480024544Ambu® Perfit Collar™0002642040002642042022-12-08
05707480024551Ambu® Perfit Collar™0002642050002642052022-12-08
05707480024568Ambu® Perfit Collar™0002642060002642062022-12-08
05707480024575Ambu® Perfit Collar™0002645010002645012022-12-08
05707480024582Ambu® Perfit Collar™0002645020002645022022-12-08
05707480024599Ambu® Perfit Collar™0002645030002645032022-12-08
05707480024605Ambu® Perfit Collar™0002645040002645042022-12-08
05707480024612Ambu® Perfit Collar™0002645050002645052022-12-08
05707480024629Ambu® Perfit Collar™0002645060002645062023-02-09
05707480024636Ambu® Perfit ACE™0002810000002810002022-12-08
05707480024643Ambu® Military Perfit ACE™000281000MIL000281000MIL2022-12-08
05707480024667Ambu® Immobilization Kit, with0002811510002811512022-12-08
05707480037315Ambu® Immobilization Kit, with0002811520002811522022-12-08
05707480038619Ambu® Immobilization Kit, with0002811530002811532022-12-08

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Primary DI, Brand, Company table
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