International safety notice
Technical Name: Esophageal pH monitor;
Brazil / Anvisa · BRA · Apr 28, 2016
Key facts
| Title | Technical Name: Esophageal pH monitor; |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Bravo pH Monitoring System / Bravo pH Capsule with Application Device ANVISA registration number: 10349000438 (Bravo pH Monitoring System) and Bravo pH Capsule with Application Device (10349000435) Risk class: 2 Model(s) affected; FGS-0312 Bravo® ph capsule delivery device, pack of 5 FGS-0313 Bravo® ph capsule delivery device, unit packaging |
| Manufacturer | DADOS DO DETENTOR DO REGISTRO NO BRASIL MEDTRONIC COMERCIAL LTDA ENDEREÇO AV JORNALISTA ROBERTO MARINHO 85 10º ANDAR CEP 04675010 SÃO PAULOSPFABRICANTE GIVEN IMAGIN INC ESTADOS UNIDOS DA AMÉRICA |
| Models | FGS-0312, 10349000438, 10349000435, FGS-0313 |
| Date | Apr 28, 2016 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1