AccessGUDID - DEVICE: NA (10886704071440)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 91-4284US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 914284US
Company Name: Medos International Sàrl

Primary DI Number: 10886704071440
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 482661753 *Terms of Use

Device Description: Bolus Kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
LKK	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
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
Handling Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 85cc7c73-93ca-4af1-934b-7a2011b17411
Public Version Date: April 03, 2024
Public Version Number: 5
DI Record Publish Date: September 20, 2014