AccessGUDID - DEVICE: Dexcom G4 Platinum Sensor (00386270000019)

GUDID

Device Identifier (DI) Information

Brand Name: Dexcom G4 Platinum Sensor
Version or Model: 9500-27
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Dexcom, Inc.

Primary DI Number: 00386270000019
Issuing Agency: GS1
Commercial Distribution End Date: April 10, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 123160736 *Terms of Use

Device Description: Sensor Applicator Assembly

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:	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?
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
MDS	Sensor, Glucose, Invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P120005	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 36 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4278e5a5-eae6-4220-8e81-ae8b19a202af
Public Version Date: April 12, 2023
Public Version Number: 6
DI Record Publish Date: September 04, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20386270000013	4	00386270000019	2023-04-10	Not in Commercial Distribution	4 Pack Retail
30386270000010	4	00386270000019	2023-04-10	Not in Commercial Distribution	4 Pack
00386270000637	4	00386270000019	2023-04-10	Not in Commercial Distribution	4 Pack (Medicare)