AccessGUDID - DEVICE: Paradigm® REAL-Time Revel™ (00643169168749)

GUDID

Device Identifier (DI) Information

Brand Name: Paradigm® REAL-Time Revel™
Version or Model: MMT-523RNAP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC MINIMED, INC.

Primary DI Number: 00643169168749
Issuing Agency: GS1
Commercial Distribution End Date: December 15, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 849626338 *Terms of Use

Device Description: PUMP MMT-523RNAP PRDGM INS 2.5 PL EN RC

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":	No
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?
35983	Ambulatory insulin infusion pump, electronic	A portable, battery-powered, electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus. It may be badge-like, designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive), or worn in a case attached to the belt or carried in a pocket. It includes a reservoir (e.g., a cartridge similar to a syringe), a pumping mechanism, and an infusion-rate controller. The pump infuses microvolume pulses and/or bolus doses of insulin subcutaneously, typically into the abdomen, through a needle or catheter (not included).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MDS	Sensor, glucose, invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P980022	031

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
Storage Environment Temperature: between -20 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 75b85807-9220-4744-9398-c83ec604becd
Public Version Date: September 12, 2018
Public Version Number: 4
DI Record Publish Date: September 23, 2014