DEVICE: ACTion Fuser Pump, 400ml, 5-15 ml/hr140mm caut-to-size catheter (05707480120222)

Device Identifier (DI) Information

ACTion Fuser Pump, 400ml, 5-15 ml/hr140mm caut-to-size catheter
418104400
Not in Commercial Distribution
418104400
Ambu A/S
05707480120222
GS1
August 06, 2018
1
305682023 *Terms of Use
ACTion Fuser 400 ml, 5-15 ml/hr, 140 mm 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

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MEB PUMP, INFUSION, ELASTOMERIC
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K061409 000
No CLOSE

Sterilization

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

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

[?]
Size Type Text
Total Volume: 400 Milliliter
Total Volume: 500 Milliliter
Length: 140 Millimeter
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Device Record Status

22d535e1-5219-499f-b3cc-6d81450b3d4c
August 07, 2018
4
September 21, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05707480120239 4 05707480120222 2018-08-06 Not in Commercial Distribution
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+14107686464
Purchase_orders@ambuUSA.com
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