DEVICE: ACTion Fuser Pump, 200ml, 1-6 ml/hrDual 140mm caut-to-size catheter (05707480121465)

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Device Identifier (DI) Information

ACTion Fuser Pump, 200ml, 1-6 ml/hrDual 140mm caut-to-size catheter
418108200
418108200
Ambu A/S
05707480121465
GS1
1
ACTion Fuser 200,1-6 ml/hr,140mm Dual Cath.,Cut-to-size
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Elastomeric infusion pump kit A 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.
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FDA Product Code

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Product Code Product Code Name
MEB PUMP, INFUSION, ELASTOMERIC
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between -15 and 40 Degrees Celsius
Handling Environment Temperature: between -50 and 50 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Total Volume: 300 Milliliter
Length: 140 Millimeter
Total Volume: 200 Milliliter
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Device Status

In Commercial Distribution
September 21, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05707480121588 4 05707480121465 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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+14107686464
Purchase_orders@ambuUSA.com
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