Data / Medical devices / Garment, Storage, Peritoneal Dialysis Catheter
Garment, Storage, Peritoneal Dialysis Catheter (OAG): 11 FDA-registered makers in 3 countries
11 establishments in 3 countries are registered with the FDA to make Garment, Storage, Peritoneal Dialysis Catheter (product code OAG, Class 1, 21 CFR 890.5050). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OAG
- Device class
- 1
- Regulation
- 890.5050
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| China | 4 |
| Ireland | 1 |
Makers of Garment, Storage, Peritoneal Dialysis Catheter
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Dongguan Well Sport Co Ltd | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Frank Stubbs | Oxnard, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan City Hubei, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Circuit (Shanghai) Ltd. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Neuromodulation | Minneapolis, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Tech Design & MFG., Inc. | Santa Fe Springs, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PRO-TECH Design & Mfg, Inc. | Santa Fe Springs, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rockfield Medical Devices Ltd. | Galway Galway(County), Ireland | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roo Healthcare Solutions LLC | Pompano Beach, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WestBridge Vocational, Inc. | Sylva, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Jasmine Oralcare Products Co., Ltd. | Jiaxing Zhejiang, China | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.