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In Touch Blood Glucose Meter

FDA UDI

Class II (US FDA UDI)

by Livongo Health, Inc

Identity

Trade Name
In Touch Blood Glucose Meter FDA UDI
Generic Name
Glucose monitoring system IVD, home-use FDA UDI
Device Name
In Touch BG 200 Blood Glucose Meter with Charger Adapter and USB Cable FDA UDI
Model / Reference
BG200 FDA UDI
Description
In Touch BG 200 Blood Glucose Meter with Charger Adapter and USB Cable FDA UDI

Identifiers

Catalog Number
FG00163 FDA UDI
Primary DI / UDI-DI
00853553005035 FDA UDI
510(k) Number
K133584 FDA UDI
FDA Product Code
NBW FDA UDI
GMDN Term
Glucose monitoring system IVD, home-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 FDA UDI
Commercial Distribution
Not 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

In Touch Blood Glucose Meter by Livongo Health, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K133584 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Livongo Health, Inc

Sources (1)

  • FDA UDI 3f406929-fa2c-48e5-9f13-85d4c24bf79f 38 fields · synced May 31, 2026