AMSure® Red Rubber Urethral Catheter
AMSure® Red Rubber Urethral Catheter: 11 catalogue numbers listed by Amsino Medical Inc., United States, under Catheter, Ureteral, Gastro-Urology. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
11catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1), Shanghai (1). 2 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 |
| Well Lead Medical (Hainan) Co., Ltd. | Haikou | Hainan | Contract manufacturer | 3 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
Record
| Listed by | Amsino Medical Inc., United States |
|---|---|
| FDA product code | EYB |
| Device type | Catheter, Ureteral, Gastro-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Repacker / relabeller |
| Record published | 2016-09-23 |
| Record revised | 2019-12-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 100, case of 3 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Coloplast | Coloplast A/S | 60 |
| Porges Coloplast | Coloplast A/S | 32 |
| Bard® Woven Ureteral Catheter | C.R. Bard, Inc. | 31 |
| Pigtail | Cook Incorporated | 18 |
| Sof-Flex | Cook Incorporated | 11 |
| Medline | Medline Industries, Inc. | 11 |
| Red Rubber Urethral Catheters | Dynarex Corp. | 9 |
| Bard® Polyurethane Ureteral Catheters, Open Tip | C.R. Bard, Inc. | 9 |
| TruCath | HR Pharmaceuticals Inc. | 8 |
| Cook | Cook Incorporated | 4 |
| Flexi-Tip | Cook Incorporated | 4 |
| Dornier MedTech | Dornier Medtech America, Inc. | 4 |
Showing 12 of 38. All products under Catheter, Ureteral, Gastro-Urology
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K030293 | 2004-02-04 |
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.