DEVICE: ACTion Fuser Pump, 650ml, 5-15 ml/hr140mm caut-to-size catheter (05707480120932)
Device Identifier (DI) Information
ACTion Fuser Pump, 650ml, 5-15 ml/hr140mm caut-to-size catheter
418104650
In Commercial Distribution
418104650
Ambu A/S
418104650
In Commercial Distribution
418104650
Ambu A/S
ACTion Fuser 650 ml, 5-15 ml/hr, 140 mm Cut-to-size
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47190 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MEB | PUMP, INFUSION, ELASTOMERIC |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K061409 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -15 and 40 Degrees Celsius |
Handling Environment Temperature: between -50 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 650 Milliliter |
Length: 140 Millimeter |
Device Record Status
b168b3c9-44aa-4953-b85b-ad41bcba4641
July 06, 2018
3
September 21, 2016
July 06, 2018
3
September 21, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05707480120949 | 4 | 05707480120932 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+14107686464
Purchase_orders@ambuUSA.com
Purchase_orders@ambuUSA.com