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Glucose Pilot

FDA UDI

Class II (US FDA UDI)

by Syntron Bioresearch, Inc.

Identity

Trade Name
Glucose Pilot FDA UDI
Generic Name
Blood glucose/blood pressure monitoring system, home-use FDA UDI
Device Name
Glucose Pilot - The Complete Glucose Monitoring System FDA UDI
Model / Reference
10001 FDA UDI
Description
Glucose Pilot - The Complete Glucose Monitoring System FDA UDI

Identifiers

Catalog Number
10001 FDA UDI
Primary DI / UDI-DI
00748349000717 FDA UDI
510(k) Number
K052208 FDA UDI
FDA Product Code
NBW FDA UDI
CGA FDA UDI
JJX FDA UDI
GMDN Term
Blood glucose/blood pressure monitoring system, home-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 FDA UDI
862.1660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Blood glucose/blood pressure monitoring system, home-use

Glucose Pilot by Syntron Bioresearch, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood glucose/blood pressure monitoring system, home-use.

Cleared under the same submission

K052208 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Syntron Bioresearch, Inc.

Sources (1)

  • FDA UDI a10c9506-0061-436e-8bf2-53b3b69a52d9 35 fields · synced May 30, 2026