AccessGUDID - DEVICE: Prometra Physician Configuration Device (00810335020181)

GUDID

Device Identifier (DI) Information

Brand Name: Prometra Physician Configuration Device
Version or Model: 12861
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Flowonix Medical, Inc.

Primary DI Number: 00810335020181
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013518517 *Terms of Use

Device Description: The Physician Configuration Device is used to configure the Patient Therapy Controller for proper use with a single Programmable Pump. It can also be used to read historical data and error logs from the Patient Therapy Controller.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
44074	Infusion pump programmer	An external device that enables a user to interrogate, test, analyse and program, noninvasively, one or more of the operating parameters (the programs) of an implanted infusion pump. It is able to read stored parameters in the infusion pump, providing historic and/or current information regarding performance, and may be used to upload new software into the infusion pump. It is a dedicated device, typically with an electronic wand with a communication antenna, connected to a port of a personal computer (PC) using dedicated software to drive the electronics of the wand to communicate with the implanted infusion pump.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKK	Pump, Infusion, Implanted, Programmable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P080012	023

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Do not get wet

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d7705fdc-5d2f-43df-8f61-9382c23d83cd
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 24, 2015