SmartPill

FDA UDI

Class II (US FDA UDI)

by Given Imaging , Ltd.

Identity

Trade Name: SmartPill FDA UDI
Generic Name: Gastrointestinal telemetric monitoring system FDA UDI
Device Name: SmartPill software v3.1 FDA UDI
Model / Reference: FGS-0658 FDA UDI
Description: SmartPill software v3.1 FDA UDI

Identifiers

Primary DI / UDI-DI: 07290110360481 FDA UDI
FDA Product Code: NYZ FDA UDI
GMDN Term: Gastrointestinal telemetric monitoring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Gastrointestinal telemetric monitoring system

SmartPill by Given Imaging , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal telemetric monitoring system.

Heidelberg pH Capsule System — Heidelberg Medical Inc · Class I
Heidelberg pH Capsule System — Heidelberg Medical Inc · Class I
Bravo — Given Imaging , Ltd. · Class I
Bravo — Given Imaging , Ltd. · Class I
SmartPill — Given Imaging , Ltd. · Class II
Bravo — Given Imaging , Ltd. · Class I
Bravo — Given Imaging , Ltd. · Class I
Bravo — Given Imaging , Ltd. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Given Imaging , Ltd.

Sources (1)

FDA UDI 44bcc65c-fd61-4045-b8da-9dbcd25f7293 34 fields · synced May 30, 2026