DEVICE: NA (10886704043720)

Device Identifier (DI) Information

NA
AP-04013-5
In Commercial Distribution
AP040135
Medos International Sàrl
10886704043720
GS1

1
482661753 *Terms of Use
Special Bolus Needle for use with CODMAN 3000 series Drug Delivery System Straight Length 1 3/8inch (3.5 cm)
CLOSE

Device Characteristics

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

FDA Product Code

[?]
Product Code Product Code Name
LKK PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

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

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

bed3ecf8-a331-4eba-ad9a-003009a3e4c8
September 18, 2020
4
September 20, 2014
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20886704043727 5 10886704043720 In Commercial Distribution CASE
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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