AccessGUDID - DEVICE: Commander Flex™ (00763000286989)

GUDID

Device Identifier (DI) Information

Brand Name: Commander Flex™
Version or Model: 101001-002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medtronic Care Management Services, LLC

Primary DI Number: 00763000286989
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061079989 *Terms of Use

Device Description: HUB CD320 CMDR FLEX - CA

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":	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?
48041	Multiple physiological parameter spot-check system, home-use	An electrically-powered device assembly designed for use in the home to spot-check (user-initiated) measure and display multiple patient physiological parameters [e.g., blood pressure, blood glucose, pulse rate, temperature, haemoglobin oxygen saturation (SpO2), and possibly calculate mean arterial pressure (MAP)]. It typically includes a main unit with a visual display intended to process/store the data, and physiological measuring components (e.g., thermometer, blood pressure cuff, blood glucose meter); it may additionally allow the data to be communicated with a healthcare professional. It may be used in a healthcare facility and in the home.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXN	System, measurement, blood-pressure, non-invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091821	000

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 -4 and 131 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8abb1bfb-952a-42f0-8362-e2caf395438e
Public Version Date: October 10, 2022
Public Version Number: 3
DI Record Publish Date: July 08, 2019