DEVICE: MEDSTREAM (10886704064954)

Device Identifier (DI) Information

MEDSTREAM
91-4288
In Commercial Distribution
914288
Medos International Sàrl
10886704064954
GS1
December 31, 2024
1
482661753 *Terms of Use
Refill Kit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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?
46024 Implantable intrathecal infusion pump, programmable
A battery-powered programmable device designed to be implanted in a patient for the storing and subarachnoid (intrathecal) administration of narcotics/drugs (e.g., morphine sulfate, baclofen) to manage intractable pain and muscle spasms of malignant or non-malignant origin. This implantable infusion pump (IIP) delivers drug doses from its implanted refillable reservoir which is controlled by drug concentration and/or by radio-frequency (RF) signals from an external programming device. The drug reservoir, usually implanted under the skin of the lower abdomen, is typically connected to a catheter placed into the spinal fluid space.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
LKK PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P890055 031
P890055 047
P890055 049
P890055 053
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Sterilization

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

[?]
Storage and Handling
Handling Environment Temperature: between 15 and 25 Degrees Celsius
Storage Environment Temperature: between 15 and 25 Degrees Celsius
Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit
Handling Environment Temperature: between 59 and 77 Degrees Fahrenheit
Special Storage Condition, Specify: Do not use if opened or damaged.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

66cc1b20-5f9c-4967-83f8-57e06d089cfc
April 03, 2024
5
September 20, 2014
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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
20886704064951 6 10886704064954 2024-12-31 In Commercial Distribution Package
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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

[?]
+1(800)255-2500
xx@xx.xx
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