Stelo Glucose Biosensor (1pk)

GUDID 00386270004345

Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Primary Device ID	00386270004345
NIH Device Record Key	3aff3270-cac3-4653-8703-4d3b0f5b2afc
Commercial Distribution Status	In Commercial Distribution
Brand Name	Stelo Glucose Biosensor (1pk)
Version Model Number	STP-XN-001
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	false
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	00386270004345 [Primary]

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

Steralize Prior To Use	false
Device Is Sterile	true

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