Bravo
Bravo CF capsule delivery dev, 5-pk
1manufacturer
9catalogue numbers in this listing
1510(k) clearance
2recalls on this code
Who Else Makes It
Registered in Chongqing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Chongqing Jinshan Science & Technology (Group) Co., Ltd. | Chongqing | Chongqing | Manufacturer | 4 |
Record
| Listed by | Given Imaging Ltd., Israel |
|---|---|
| FDA product code | FFT |
| Device type | Electrode, Ph, Stomach |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1400 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-08-29 |
| Record revised | 2024-11-15 (version 9) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment temperature 20 to 45 °C; Storage environment temperature 15 to 45 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| FGS-0313 | In distribution | ||
| FGS-0634 | In distribution | ||
| FGS-0516 | 5 | In distribution | |
| FGS-0635 | 5 | In distribution | |
| FGS-0312 | 5 | In distribution | |
| FGS-0450 | In distribution | ||
| RFB-0450 | In distribution | ||
| FGS-0636 | In distribution | ||
| FGS-0593 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diversatek Healthcare | Diversatek Healthcare Inc | 36 |
| Versaflex | Given Imaging Ltd. | 35 |
| Heidelberg pH Capsule System | Heidelberg Medical Inc | 7 |
| Restech | THE Reflux Company | 6 |
| alpHaONE | Chongqing Jinshan Science & Technology (Group) Co., Ltd. | 4 |
| Electrode, Ph, Stomach | Given Imaging Ltd. | 3 |
| Reflux | Given Imaging Ltd. | 2 |
| 2 channel pH antimony, 21 cm spacing, 6.4 Fr | Medical Measurement Systems B.V. | 1 |
| 2 channel pH antimony, 15 cm spacing, 6.4 Fr | Medical Measurement Systems B.V. | 1 |
| 2 channel pH antimony, 10 cm spacing, 6.4 Fr | Medical Measurement Systems B.V. | 1 |
| 1 channel pH antimony, 6.4 Fr | Medical Measurement Systems B.V. | 1 |
| Digitrapper | Given Imaging Ltd. | 1 |
Showing 12 of 14. All products under Electrode, Ph, Stomach
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102543 | 2010-12-01 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Given Imaging Ltd. | UDI-DI | 2026-08-06 | Not classified | Nonconforming Material/Component | Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a | 127,416 |
| Given Imaging Ltd. | UDI-DI | 2025-06-03 | Class I | Process control | It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient’s esophagus or detaching from t | 128,202 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.