DEVICE: DOSI-FUSER (08436020764868)

Device Identifier (DI) Information

DOSI-FUSER
L25915-150D2-FDA
Not in Commercial Distribution

LEVENTON SAU
08436020764868
GS1
March 14, 2018
1
461437429 *Terms of Use
Elastomeric Infusion Pump
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
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?
46542 Elastomeric infusion pump system
An assembly of devices that provides continuous and/or intermittent percutaneous infusion of a prescribed medicated solution to a patient through forces from elastic material. It typically consists of an elastomeric chamber (various sizes predetermine the flow and volume) that is filled with the solution using a dedicated filling device and/or syringe to create a pressure, tubing, particulate/air-eliminating filter, a flow restrictor, and a connector at the distal end for connection to the patient's access device. It may be used for general infusion, antibiotic delivery, chemotherapy, or pain management in either a healthcare facility or in 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 [?]
K040752 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 150 Milliliter
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Device Record Status

d9f91dd3-5ee4-47c9-acca-e63cf8524c9c
July 06, 2018
3
August 31, 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
18436020764865 10 08436020764868 2018-03-14 Not in Commercial Distribution Box
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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
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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