Stelo Biosensor

GUDID 00386270004338

Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Primary Device ID	00386270004338
NIH Device Record Key	e61da9d5-2bf0-47ef-9f0b-fcf2574b129e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Stelo Biosensor
Version Model Number	9500-174
Company DUNS	123160736
Company Name	Dexcom, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Device Issuing Agency	Device ID
GS1	00386270004338 [Primary]

SAF	Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter

Steralize Prior To Use	false
Device Is Sterile	true

00386270004635 - Dexcom Stelo iOS Mobile App	2024-08-23
00386270004642 - Dexcom Stelo Android Mobile App	2024-08-23
00386270004659 - Dexcom Stelo iOS Watch App	2024-08-23
00386270004550 - Dexcom G7 GSS (1)	2024-06-26 G7 GSS US (1pk) -161 (Government Payor)
00386270004338 - Stelo Biosensor	2024-04-03Stelo Biosensor
00386270004338 - Stelo Biosensor	2024-04-03 Stelo Biosensor
00386270004345 - Stelo Glucose Biosensor (1pk)	2024-04-03 Stelo Glucose Biosensor US (1pk)
00386270004383 - Stelo Glucose Biosensor (2pk)	2024-04-03 Stelo Glucose Biosensor US (2pk)
00386270004390 - Stelo Glucose Biosensor (1pk) UPC	2024-04-03 Stelo Glucose Biosensor US (1pk)