AccessGUDID - DEVICE: MEDSTREAM (10886704064923)

GUDID

Device Identifier (DI) Information

Brand Name: MEDSTREAM
Version or Model: 91-4200US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 91-4200US
Company Name: Cerenovus, Inc.

Primary DI Number: 10886704064923
Issuing Agency: GS1
Commercial Distribution End Date: September 28, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 607846297 *Terms of Use

Device Description: Programmable Infusion System Includes: MEDSTREAM Pump;Pump Catheter;Operating Room Prep Kit;Pump Documentation and Information Manual

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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":	No
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

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
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 50 Degrees Celsius
Handling Environment Temperature: between 5 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 097ada30-df24-42cf-b8ee-e68d8ea4b810
Public Version Date: September 15, 2023
Public Version Number: 4
DI Record Publish Date: September 20, 2014