Bravo

FDA UDI

Class I (US FDA UDI)

by Given Imaging , Ltd.

Identity

Trade Name: Bravo FDA UDI
Generic Name: Gastrointestinal telemetric monitoring system FDA UDI
Device Name: pH recorder SW upgrade v136 FDA UDI
Model / Reference: FGS-0593 FDA UDI
Description: pH recorder SW upgrade v136 FDA UDI

Identifiers

Primary DI / UDI-DI: 07290101366393 FDA UDI
FDA Product Code: FFT FDA UDI
GMDN Term: Gastrointestinal telemetric monitoring system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.1400 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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Gastrointestinal telemetric monitoring system

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

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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 I	Pending data

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Manufacturer

Manufacturer: Given Imaging , Ltd.

Sources (1)

FDA UDI e7aa0f7a-e548-4279-9fc1-a6df264561b8 34 fields · synced May 30, 2026