Apogee IC
Intermittent catheter, 14 Fr 6 in, Straight, No Funnel
11manufacturers in China registered for this device type
21catalogue numbers in this listing
11510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (6), Jiangsu (4), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Integral Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Xianju Bever Medical Devices Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 3 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Nanjing Anjian Medical Device Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 22 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Hangzhou Jimushi Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Integral Sterilization Technology (Shaoxing) Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 5 |
| Hangzhou Bever Medical Devices Co., Ltd. | Hangzhou | Zhejiang | Specification developer | 3 |
| Xianju JF Medister Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 2 |
Record
| Listed by | Hollister Incorporated, United States |
|---|---|
| FDA product code | GBM |
| Device type | Catheter, Urethral |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-21 |
| Record revised | 2018-03-29 (version 2) |
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 |
| Packaging | Case of 12 |
| Sizes | Catheter gauge 6 to 18 Fr; length 6 to 16 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 11016 | Catheter Gauge 10 Fr | 30 | In distribution |
| 10616 | Catheter Gauge 6 Fr | 30 | In distribution |
| 11226 | Catheter Gauge 12 Fr | 30 | In distribution |
| 11026 | Catheter Gauge 10 Fr | 30 | In distribution |
| 11826 | Catheter Gauge 18 Fr | 30 | In distribution |
| 11816 | Catheter Gauge 18 Fr | 30 | In distribution |
| 10826 | Catheter Gauge 8 Fr | 30 | In distribution |
| 10610 | Length 10 in | 30 | In distribution |
| 11626 | Length 16 in | 30 | In distribution |
| 10816 | Catheter Gauge 8 Fr | 30 | In distribution |
| 11406 | Catheter Gauge 14 Fr | 30 | In distribution |
| 11446 | Length 6 in | 30 | In distribution |
| 10810 | Catheter Gauge 8 Fr | 30 | In distribution |
| 11416 | Catheter Gauge 14 Fr | 30 | In distribution |
| 11206 | Length 6 in | 30 | In distribution |
| 11010 | Catheter Gauge 10 Fr | 30 | In distribution |
| 11216 | Length 16 in | 30 | In distribution |
| 10806 | Catheter Gauge 8 Fr | 30 | In distribution |
| 11616 | Length 16 in | 30 | In distribution |
| 11006 | Catheter Gauge 10 Fr | 30 | In distribution |
| 11426 | Length 16 in | 30 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BeneCath® | Hangzhou Jimushi Meditech Co., Ltd. | 57 |
| SpeediCath Standard | Coloplast A/S | 47 |
| TruCath | HR Pharmaceuticals Inc. | 46 |
| VaPro | Hollister Incorporated | 31 |
| Actreen® | B. Braun Medical Inc. | 28 |
| McKesson | Mckesson Medical-Surgical Inc. | 25 |
| BD Intermittent | Hangzhou Bever Medical Devices Co., Ltd. | 24 |
| Gentlecath AIR | Convatec, Purchasing Department | 24 |
| VaPro Pocket | Hollister Incorporated | 23 |
| Apogee | Hollister Incorporated | 23 |
| Dover | Cardinal Health | 23 |
| Dover | Cardinal Health 200, LLC | 22 |
Showing 12 of 76. All products under Catheter, Urethral
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211436 | 2022-01-27 |
| K193148 | 2019-12-13 |
| K191633 | 2019-07-19 |
| K183253 | 2018-12-18 |
| K180824 | 2018-06-22 |
| K163179 | 2017-01-26 |
| K152268 | 2015-09-09 |
| K143594 | 2015-01-09 |
| K141642 | 2014-08-22 |
| K110862 | 2011-04-26 |
| K090960 | 2009-08-20 |
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.