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GlucoTrack Solution Level 2

FDA UDI

Class I (US FDA UDI)

by Philosys, Inc.

Identity

Trade Name
GlucoTrack Solution Level 2 FDA UDI
Generic Name
Glucose monitoring system IVD, home-use FDA UDI
Model / Reference
GT-C02 FDA UDI

Identifiers

Primary DI / UDI-DI
08809301168066 FDA UDI
510(k) Number
K113636 FDA UDI
K131230 FDA UDI
K141656 FDA UDI
K150299 FDA UDI
K151658 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Glucose monitoring system IVD, home-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Glucose monitoring system IVD, home-use

GlucoTrack Solution Level 2 by Philosys, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glucose monitoring system IVD, home-use.

Cleared under the same submission

K113636 also covers:

K131230 also covers:

K141656 also covers:

K150299 also covers:

K151658 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philosys, Inc.

Sources (1)

  • FDA UDI 7b9c04d6-efae-4683-9cab-0e7ba88a92c7 33 fields · synced Jun 8, 2026