Ambu® ACTion™ Fuser Pump

Primary DI
05707480156122
Brand
Ambu® ACTion™ Fuser Pump
Company
Ambu A/S
Model
418103200M
Catalog number
418103200M
Device description
"Action Fuser, 200 mL, 1-6 mL/hr Reg, 140 mm Cath, 6"" intro"
Published
2022-02-03
Public version status
Update
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
K061409000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061409000SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SETPrecise Medical Products, Ltd.2006-06-16MEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05707480156115PackageGS15In Commercial Distribution
05707480156122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707480156115057074801561155707480156115
05707480156122057074801561225707480156122

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical infusion pump administration setA collection of devices intended to be used with a mechanical infusion pump (non-electric) to enable the intermittent or continuous infusion of medication (not included), typically for antibiotic therapy, chemotherapy, or pain management [including patient-controlled analgesia (PCA)] by intravenous (IV), subcutaneous, intramuscular, or epidural routes. It typically consists of a reservoir (e.g., a plastic pouch), plastic tubing, a check valve, a line clamp, and Luer connectors. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume200Milliliter

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

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