Dexcom G4 Platinum (Pedicatric) Receiver Kit - G4 Platinum (Pediatric) Receiver Kit Black - Dexcom, Inc.

Duns Number:123160736

Device Description: G4 Platinum (Pediatric) Receiver Kit Black

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More Product Details

Catalog Number

-

Brand Name

Dexcom G4 Platinum (Pedicatric) Receiver Kit

Version/Model Number

STK-KD-001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P120005

Product Code Details

Product Code

MDS

Product Code Name

Sensor, Glucose, Invasive

Device Record Status

Public Device Record Key

ab3be772-b54a-41b2-9a57-e61ac24b8b75

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 12, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEXCOM, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 2
3 A medical device with high risk that requires premarket approval 72