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Lingo

FDA UDI

Class II (US FDA UDI)

by Abbott Diabetes Care Inc

Identity

Trade Name
Lingo FDA UDI
Generic Name
Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
Device Name
Lingo Biosensor iOS App US FDA UDI
Model / Reference
78783-01 FDA UDI
Description
Lingo Biosensor iOS App US FDA UDI

Identifiers

Catalog Number
78783-01 FDA UDI
Primary DI / UDI-DI
00357599849009 FDA UDI
FDA Product Code
SAF FDA UDI
GMDN Term
Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1355 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical

Lingo by Abbott Diabetes Care Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Percutaneous interstitial fluid glucose monitoring system, electrochemical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Diabetes Care Inc

Sources (1)

  • FDA UDI 369c9f88-8acf-4a2b-a3bb-d0743e7125ee 35 fields · synced May 31, 2026