Mon-a-Therm
Foley with Temperature Sensor 400TM
9manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (3), Guangdong (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Guangdong Ecan Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 14 |
| Clinisupplies (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 13 |
| Integral Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Hangzhou Jimushi Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Integral Sterilization Technology (Shaoxing) Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | KOD |
| Device type | Catheter, Urological |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| 510(k) | K831567 |
| Record published | 2023-05-29 |
| Record revised | 2026-07-16 (version 16) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment humidity 10 to 95 % RH; Handling environment atmospheric pressure 12 to 106 KiloPascal; Handling environment temperature -13 to 131 °F |
| Packaging | Case of 2, pack_or_inner_pack of 10 |
| Sizes | Catheter gauge 8 to 18 Fr |
| Distribution end date | 2026-05-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 90054 | Catheter Gauge 10 Fr | Withdrawn |
| 90052 | Catheter Gauge 18 Fr | Withdrawn |
| 90056 | Catheter Gauge 14 Fr | Withdrawn |
| 90055 | Catheter Gauge 12 Fr | Withdrawn |
| 90056 | Catheter Gauge 14 Fr | Withdrawn |
| 90053 | Catheter Gauge 8 Fr | Withdrawn |
| 90051 | Catheter Gauge 16 Fr | Withdrawn |
| 90052 | Catheter Gauge 18 Fr | Withdrawn |
| 90053 | Catheter Gauge 8 Fr | Withdrawn |
| 90054 | Catheter Gauge 10 Fr | Withdrawn |
| 90055 | Catheter Gauge 12 Fr | Withdrawn |
| 90051 | Catheter Gauge 16 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 432 |
| Dover | Cardinal Health 200, LLC | 163 |
| Dover | Cardinal Health | 152 |
| MTG | HR Pharmaceuticals Inc. | 59 |
| Cook | Cook Incorporated | 43 |
| Bardex® Lubricath® Foley Catheter | C.R. Bard, Inc. | 30 |
| Magic3™ Intermittent Catheter | C.R. Bard, Inc. | 30 |
| Ureteral Catheter | Well Lead Medical Co., Ltd. | 26 |
| Bardex® Urethral Catheter Robinson Model | C.R. Bard, Inc. | 26 |
| Personal Catheter™ Intermittent Catheter | C.R. Bard, Inc. | 24 |
| DeRoyal | Deroyal Industries, Inc. | 23 |
| Bard® Robinson Catheter | C.R. Bard, Inc. | 22 |
Showing 12 of 150. All products under Catheter, Urological
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.