DEVICE: NA (10886704078845)

Device Identifier (DI) Information

NA
IP40820US
In Commercial Distribution
IP40820US
Medos International Sàrl
10886704078845
GS1

1
482661753 *Terms of Use
Models 400 and 550 Implantable Infusion Pump Refill Kit Contents: (1) 50 ml Calibrated Syringe Barrel (1) Tubing Set with Removable Injection Site (1) Stopcock (2) Huber Point Needles 22 Gauge x 1inch (2.54 cm) (2) Huber Point Needles 22 Gauge x 1.5inch (3.8 cm) (6) Gauze Pads (1) Fenestrated Drape (2) Pump Templates (2) Adhesive Bandages (1) Refill Worksheet (1) Set of INSTRUCTIONS FOR USE
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Implantable intrathecal infusion pump, nonprogrammable A battery-powered, nonprogrammable, sterile device designed to be implanted in a patient for the storing and subarachnoid 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) may enable delivery of a bolus of medication, typically patient-controlled with mechanical restrictions that limit the refill rate of the device, or it may provide a constant flow of medication at a factory-set rate. The device typically consists of a drug reservoir, usually implanted under the skin of the lower abdomen, and a connected catheter placed into the spinal fluid space.
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
P800036 024
P800036 029
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Sterilization

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

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Storage and Handling
Handling Environment Temperature: between 59 and 77 Degrees Fahrenheit
Handling Environment Temperature: between 15 and 25 Degrees Celsius
Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 15 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

a6dcc439-044b-44a6-8568-1b1795ed9b8f
September 18, 2020
5
April 13, 2015
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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
No Package DIs found
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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

[?]
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

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Yes
No
Yes
No
No CLOSE

Customer Contact

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