AccessGUDID - DEVICE: Dexcom Replacement Receiver Kit (30386270000324)

GUDID

Device Identifier (DI) Information

Brand Name: Dexcom Replacement Receiver Kit
Version or Model: STR-SD-001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Dexcom, Inc.

Primary DI Number: 30386270000324
Issuing Agency: GS1
Commercial Distribution End Date: April 04, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 123160736 *Terms of Use

Device Description: Replacement Receiver 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":	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?
44611	Percutaneous interstitial-fluid glucose monitoring system, electrochemical	An assembly of electrically-powered, portable devices intended to continuously monitor interstitial-fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously-inserted electrode that physically connects to a cable or transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system may be used in the home and clinical settings, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PQF	Sensor, Glucose, Invasive, Non-Adjunctive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P120005	050

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 Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 32 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 719ac8c9-834b-48b2-987f-0f5a6eaa1bda
Public Version Date: April 05, 2023
Public Version Number: 6
DI Record Publish Date: April 10, 2017