AccessGUDID - DEVICE: MEDSTREAM (10886704071433)

GUDID

Device Identifier (DI) Information

Brand Name: MEDSTREAM
Version or Model: 91-4283US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 914283US
Company Name: Codman Neuro Sciences Sàrl

Primary DI Number: 10886704071433
Issuing Agency: GS1
Commercial Distribution End Date: September 28, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 481401680 *Terms of Use

Device Description: Refill 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?
35687	General-purpose implantable infusion pump, programmable	A battery-powered, sterile device designed to be implanted in a patient for the long-term or intermittent infusion of narcotics, short-acting anaesthetic agents, antineoplastic drugs, and other agents. This implantable infusion pump (IIP) delivers drug doses from its implanted reservoir which is controlled by drug concentration and/or by radio-frequency (RF) signals from an external programming device. A catheter connected to the reservoir is inserted into the epidural or subarachnoid (intrathecal) space of the spinal canal or into a blood vessel.	Obsolete	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P890055	026
P890055	047

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 64efcae0-f1db-4f50-ba88-8f64b49b8c78
Public Version Date: January 31, 2022
Public Version Number: 3
DI Record Publish Date: September 20, 2014