Closed Wound Suction
ReliaVac 100 Closed Wound Suction Kit, Medium Suction, 100cc Evacuator, Y-Connecting Tube, Silicone Round Drain, Medium-Large 3/16", (4.7mm) O.D., 10"(25.4cm) Hole Pattern, X-Ray Opaque…
ReliaVac 100 Closed Wound Suction Kit, Medium Suction, 100cc Evacuator, Y-Connecting Tube, Silicone Round Drain, Medium-Large 3/16″, (4.7mm) O.D., 10″(25.4cm) Hole Pattern, X-Ray Opaque Stripe, Attached Trocar
58manufacturers in China registered for this device type
37catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (19), Guangdong (14), Zhejiang (9). 15 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Firstar Healthcare Company Limited (Guangzhou) | Guangzhou | Guangdong | Contract manufacturer | 57 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Changshu Beyond Medical Device Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 9 |
| Fansheng Technology (Guangdong) Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 8 |
Showing 12 of 58. All 58 manufacturers in China registered for Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Record
| Listed by | C.R. Bard, Inc., United States |
|---|---|
| FDA product code | GCY |
| Device type | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4680 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-22 |
| Record revised | 2021-02-05 (version 2) |
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 | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 2, box of 5, box of 10, case of 10 |
| Sizes | Catheter gauge 7 to 19 Fr; width 7 to 10 mm; length 20 cm; total volume 100 to 400 ml; outer diameter 3.2 to 4.7 mm; length 36 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0071200 | Total Volume 200 ml | In distribution |
| 0070490 | Catheter Gauge 15 Fr | In distribution |
| 0090380 | Width 7 mm | In distribution |
| 0085390 | Width 10 mm | In distribution |
| 0090360 | Width 7 mm | In distribution |
| 0043630 | Catheter Gauge 15 Fr | In distribution |
| 0034620 | Catheter Gauge 19 Fr | In distribution |
| 0070400 | Total Volume 400 ml | In distribution |
| 0072360 | Width 7 mm | In distribution |
| V0070740 | Total Volume 100 ml | In distribution |
| 0072430 | Width 7 mm | In distribution |
| 0034600 | Catheter Gauge 7 Fr | In distribution |
| 0043660 | Catheter Gauge 10 Fr | In distribution |
| 0072370 | Width 10 mm | In distribution |
| 0071370 | Width 10 mm | In distribution |
| 0085320 | Outer Diameter 4.7 mm | In distribution |
| 0043620 | Catheter Gauge 19 Fr | In distribution |
| 0070740 | Total Volume 100 ml | In distribution |
| 0043670 | Catheter Gauge 19 Fr | In distribution |
| 0071430 | Width 7 mm | In distribution |
| 0090390 | Length 20 cm | In distribution |
| 0070900 | Total Volume 100 ml | In distribution |
| 0043610 | Catheter Gauge 10 Fr | In distribution |
| 0070510 | Catheter Gauge 19 Fr | In distribution |
| 0070850 | Total Volume 100 ml | In distribution |
| V0043610 | Catheter Gauge 10 Fr | In distribution |
| 0071440 | Width 10 mm | In distribution |
| 0034630 | Catheter Gauge 15 Fr | In distribution |
| 0034610 | Catheter Gauge 10 Fr | In distribution |
| 0072440 | Width 10 mm | In distribution |
| 0043650 | In distribution | |
| 0085310 | Outer Diameter 3.2 mm | In distribution |
| 0071360 | Width 7 mm | In distribution |
| 0085380 | Width 7 mm | In distribution |
| 0070480 | Catheter Gauge 10 Fr | In distribution |
| 0090370 | Length 20 cm | In distribution |
| 0043600 | Catheter Gauge 7 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioseal Inc. | Bioseal | 169 |
| Cardinal Health | Cardinal Health 200, LLC | 50 |
| Closed Suction | Sunset Healthcare Solutions, Inc. | 49 |
| Barovac® Evacuator Closed Wound Drainage System(SS) | Sewoon Medical Co., Ltd. | 33 |
| Hemovac® Wound Drainage System | Zimmer Orthopaedic Surgical Products | 23 |
| Barovac® Evacuator Closed Wound Drainage System(PP) | Sewoon Medical Co., Ltd. | 22 |
| Deluxe Closed Suction System 72hr | Sunset Healthcare Solutions, Inc. | 20 |
| Tru-Close Suction Drainage System | Uresil, LLC | 19 |
| Deluxe Closed Suction System | Sunset Healthcare Solutions, Inc. | 19 |
| Tracheostomy and Suction Accessory | Sunset Healthcare Solutions, Inc. | 18 |
| S-Vac® Fluted Channel Drain | Aspen Surgical Products, Inc. | 17 |
| Aspen® Discrete Drain | Aspen Surgical Products, Inc. | 16 |
Showing 12 of 110. All products under Apparatus, Suction, Single Patient Use, Portable, Nonpowered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K851084 | 1985-06-04 |
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.