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Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 18 Fr 16 in, Straight
9manufacturers in China registered for this device type
11catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Hollister Incorporated, United States |
|---|---|
| FDA product code | KOD |
| Device type | Catheter, Urological |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-21 |
| Record revised | 2021-12-06 (version 4) |
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 |
| Packaging | Case of 4 |
| Sizes | Catheter gauge 6 to 18 Fr; length 16 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 94184IC | Catheter Gauge 18 Fr | 25 | In distribution |
| 94144IC | Length 16 in | 25 | In distribution |
| 94064IC | Catheter Gauge 6 Fr | 25 | In distribution |
| 94084IC | Catheter Gauge 8 Fr | 25 | In distribution |
| 95144IC | Catheter Gauge 14 Fr | 25 | In distribution |
| 94104IC | Catheter Gauge 10 Fr | 25 | In distribution |
| 97164 | Catheter Gauge 16 Fr | 25 | In distribution |
| 94164IC | Length 16 in | 25 | In distribution |
| 95124IC | Catheter Gauge 12 Fr | 25 | In distribution |
| 95164IC | Length 16 in | 25 | In distribution |
| 94124IC | Catheter Gauge 12 Fr | 25 | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K013483 | 2002-01-14 |
| K013345 | 2002-01-07 |
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.