Roo Defender
Case of 10 boxes of 100 count boxes of non-sterile Roo Defender Catheter covers
4manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Hubei (1), Shanghai (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Well Sport Co Ltd | Dongguan | Guangdong | Contract manufacturer | 7 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Zhejiang Jasmine Oralcare Products Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 17 |
Record
| Listed by | ROO Healthcare Solutions LLC, United States |
|---|---|
| FDA product code | OAG |
| Device type | Garment, Storage, Peritoneal Dialysis Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5050 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-05-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RHSRD1000 | In distribution | |
| RHSRD100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Garment, Storage, Peritoneal Dialysis Catheter | Medtronic, Inc. | 3 |
| Mobility+ Enteral Feeding Device Bag Black | Rockfield Medical Devices Ltd. | 1 |
| Mobility+ Enteral Feeding Device Bag Purple | Rockfield Medical Devices Ltd. | 1 |
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.