Peco
Box PECO™ 10" Pediatric, 12 Fr. Straight Intermittent Catheter
11manufacturers in China registered for this device type
19catalogue numbers in this listing
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 | Peco Medical Inc. |
|---|---|
| FDA product code | GBM |
| Device type | Catheter, Urethral |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| 510(k) | K111405 |
| Record published | 2017-09-08 |
| Record revised | 2021-08-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Storage | Storage environment temperature 59 to 86 °F |
| Sizes | Length 7.5 to 16 in; catheter gauge 6 to 18 Fr |
| Distribution end date | 2020-01-10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PU006 | Length 10 in | 30 | Withdrawn |
| PU012F | Length 7.5 in | 30 | Withdrawn |
| PU012 | Length 16 in | 30 | Withdrawn |
| PU012P | Length 10 in | 30 | Withdrawn |
| PU014P | Length 10 in | 30 | Withdrawn |
| PU008 | Length 10 in | 30 | Withdrawn |
| PU010F | Length 7.5 in | 30 | Withdrawn |
| PU010 | Catheter Gauge 10 Fr | 30 | Withdrawn |
| PU016 | Catheter Gauge 16 Fr | 30 | Withdrawn |
| PU008L | Catheter Gauge 8 Fr | 30 | Withdrawn |
| PU018F | Length 7.5 in | 30 | Withdrawn |
| PU014 | Catheter Gauge 14 Fr | 30 | Withdrawn |
| PU014FN | Length 7.5 in | 30 | Withdrawn |
| PU018 | Length 16 in | 30 | Withdrawn |
| PU006L | Length 16 in | 30 | Withdrawn |
| PU014F | Length 7.5 in | 30 | Withdrawn |
| PU008F | Length 7.5 in | 30 | Withdrawn |
| PU016F | Length 7.5 in | 30 | Withdrawn |
| PU010L | Catheter Gauge 10 Fr | 30 | Withdrawn |
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
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.