Breeze® APD
10F X 20CM Breeze® ALL Purpose Drain With Locking Mini Pigtail SET
6manufacturers in China registered for this device type
38catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Dongguan TT Medical, Inc. | Dongguan | Guangdong | Manufacturer | 4 |
| LEO Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Medical Components Inc, United States |
|---|---|
| FDA product code | FGE |
| Device type | Stents, Drains And Dilators For The Biliary Ducts |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2022-02-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 20, inner box of 5 |
| Distribution end date | 2022-02-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BALPN1020S | In distribution | |
| BANPN1625S | In distribution | |
| BALPN0725S | In distribution | |
| BALPN1025S | In distribution | |
| BALMN0825S | In distribution | |
| BALPN0625S | In distribution | |
| BALPN0730S | In distribution | |
| BANPN0820S | In distribution | |
| BALMN1020S | In distribution | |
| BANPN0725S | In distribution | |
| BALPN1225S | In distribution | |
| BALPN0835S | In distribution | |
| BALMN1025S | In distribution | |
| BALPN1625S | In distribution | |
| BALPN1030S | In distribution | |
| BALMN0820S | In distribution | |
| BANPN1425S | In distribution | |
| BANPN1025S | In distribution | |
| BALPN1035S | In distribution | |
| BALPN0825S | In distribution | |
| BALPN1630S | In distribution | |
| BANPN0625S | In distribution | |
| BALPN1425S | In distribution | |
| BALMN0620S | In distribution | |
| BALPN1430S | In distribution | |
| BALPN0830S | In distribution | |
| BALPN0820S | In distribution | |
| BANPN0620S | In distribution | |
| BANPN0825S | In distribution | |
| BALPN1230S | In distribution | |
| BANPN0720S | In distribution | |
| BALPN0630S | In distribution | |
| BANPN1020S | In distribution | |
| BANPN1225S | In distribution | |
| BALPN1635S | Withdrawn | |
| BALPN1235S | Withdrawn | |
| BALPN1435S | Withdrawn | |
| BALPN0735S | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Zimmon | Cook Ireland Ltd | 213 |
| Single Use Biliary Drainage Stent V | Olympus Medical Systems Corp. | 181 |
| Mustang™ | Boston Scientific Corporation | 167 |
| Geenen | Cook Ireland Ltd | 158 |
| Cotton-Leung | Cook Ireland Ltd | 144 |
| Advanix™ Pancreatic Stent | Boston Scientific Corporation | 135 |
| Single Use Biliary Stent V | Olympus Medical Systems Corp. | 106 |
| Single-use Balloon Dilatation Catheter | LEO Medical Co., Ltd. | 102 |
| Biliary Plastic Stent Set | Micro-Tech (Nanjing) Co., Ltd. | 90 |
| Biliary Plastic Stent | Micro-Tech (Nanjing) Co., Ltd. | 90 |
| M-Drain | Mermaid Medical A/S | 86 |
| Advanix™ Biliary | Boston Scientific Corporation | 84 |
Showing 12 of 212. All products under Stents, Drains And Dilators For The Biliary Ducts
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.