DeRoyal
Canister Liner 3200CCW/1 Elbow and 72IN Funnel Tbg
88manufacturers in China registered for this device type
191catalogue numbers in this listing
4recalls on this code
Who Else Makes It
Concentrated in Guangdong (26), Jiangsu (25), Zhejiang (17). 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 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| JIE GAO Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Changzhou Health Microport Medical Device Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Rongxing Plastic Jurong Co., Ltd. | Zhenjiang | Jiangsu | Contract manufacturer | 8 |
| Zhejiang Aicor Medical Technology Co., Ltd. | Linhai | Zhejiang | Contract manufacturer | 4 |
Showing 12 of 88. All 88 manufacturers in China registered for Bottle, Collection, Vacuum
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | KDQ |
| Device type | Bottle, Collection, Vacuum |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6740 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-12 |
| Record revised | 2022-11-28 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 32, case of 50, case of 30, case of 10, case of 20, case of 40 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71-2040 | In distribution | |
| 5036-01 | In distribution | |
| NP-0450N | In distribution | |
| V71-9301 | In distribution | |
| 71-2071 | In distribution | |
| 71-9108 | In distribution | |
| 71-2032 | In distribution | |
| PHER-2500B | In distribution | |
| 71-2051 | In distribution | |
| V71-6530 | In distribution | |
| 71-1132 | In distribution | |
| 71-9101 | In distribution | |
| NSMNP-0450 | In distribution | |
| 30-4034S | In distribution | |
| 71-3007 | In distribution | |
| V71-6515 | In distribution | |
| 71-3003 | In distribution | |
| 71-1000BRB | In distribution | |
| 71-9201 | In distribution | |
| 71-9208 | In distribution | |
| 71-3108 | In distribution | |
| PHER-1500B | In distribution | |
| 6036-680 | In distribution | |
| 71-1500BR | In distribution | |
| 71-8004 | In distribution | |
| 71-3001 | In distribution | |
| NP-1005 | In distribution | |
| 30-4071 | In distribution | |
| 71-1800DS | In distribution | |
| 71-1000DS | In distribution | |
| 71-1800BRB | In distribution | |
| 71-6530 | In distribution | |
| 71-8010 | In distribution | |
| 71-2099NF | In distribution | |
| 71-1300BR | In distribution | |
| 71-3010 | In distribution | |
| 71-3009 | In distribution | |
| 71-3200BR | In distribution | |
| 71-9106 | In distribution | |
| NP-ST0450 | In distribution | |
| 71-6539 | In distribution | |
| 71-3000T | In distribution | |
| 71-3000BR | In distribution | |
| 71-3016 | In distribution | |
| PHER-1200B | In distribution | |
| 71-1300DS | In distribution | |
| 71-1000BR | In distribution | |
| 71-3008 | In distribution | |
| 71-8000 | In distribution | |
| 71-2053 | In distribution | |
| NP-0250-01 | In distribution | |
| 30-4066 | In distribution | |
| 71-8003 | In distribution | |
| 71-2041 | In distribution | |
| 71-3105 | In distribution | |
| 71-3002C | In distribution | |
| 6036-LF | In distribution | |
| 47-0250 | In distribution | |
| 71-1107 | In distribution | |
| 30-F512 | In distribution | |
| 71-1155 | In distribution | |
| 71-9105 | In distribution | |
| 71-0805 | In distribution | |
| 71-CART | In distribution | |
| 71-9206 | In distribution | |
| 6036-50 | In distribution | |
| 71-9304 | In distribution | |
| 71-1500BRB | In distribution | |
| 71-7131 | In distribution | |
| PHESL-1500B | In distribution | |
| PHESL-3000B | In distribution | |
| 71-3000BRB | In distribution | |
| 71-0800 | In distribution | |
| 71-1103 | In distribution | |
| 71-9202 | In distribution | |
| 71-8005 | In distribution | |
| 71-3101 | In distribution | |
| V71-1105 | In distribution | |
| 30-F503 | In distribution | |
| 71-2089 | In distribution | |
| 47-0450 | In distribution | |
| 71-6522 | In distribution | |
| 71-6527 | In distribution | |
| 71-1500T | In distribution | |
| 71-1000DSB-C | In distribution | |
| 71-6529 | In distribution | |
| 30-F506 | In distribution | |
| PHERDN-1200B | In distribution | |
| 71-8009 | In distribution | |
| 30-4067 | In distribution | |
| 71-9305 | In distribution | |
| 71-1000DSB | In distribution | |
| 71-8011 | In distribution | |
| 30-4069A | In distribution | |
| NP-0250N | In distribution | |
| 71-2034 | In distribution | |
| 71-1500DS | In distribution | |
| 71-2035 | In distribution | |
| 71-6515 | In distribution | |
| 71-6532 | In distribution | |
| NP-0450 | In distribution | |
| 71-8001 | In distribution | |
| 71-9306 | In distribution | |
| 71-3017 | In distribution | |
| 71-1166 | In distribution | |
| 6036-SM | In distribution | |
| V71-1107 | In distribution | |
| 71-9100 | In distribution | |
| 71-9102 | In distribution | |
| 71-6518 | In distribution | |
| 71-6512 | In distribution | |
| 71-3000BRB-C | In distribution | |
| 30-4033S | In distribution | |
| 71-3001NF | In distribution | |
| NP-0250 | In distribution | |
| 71-1500DSB | In distribution | |
| 71-3110 | In distribution | |
| 71-1110 | In distribution | |
| 71-9205 | In distribution | |
| NP-1002 | In distribution | |
| 71-1051 | In distribution | |
| 30-I950 | In distribution | |
| 71-1000T | In distribution | |
| 71-1101 | In distribution | |
| V71-9201 | In distribution | |
| 6036-00 | In distribution | |
| 71-2080 | In distribution | |
| 71-1300DSB | In distribution | |
| V71-6510 | In distribution | |
| 71-2079 | In distribution | |
| 71-9300 | In distribution | |
| 71-1131 | In distribution | |
| 71-1171 | In distribution | |
| 71-1300BRB | In distribution | |
| 30-F501 | In distribution | |
| 71-1189 | In distribution | |
| 32-1987 | In distribution | |
| 30-4036 | In distribution | |
| 71-1176 | In distribution | |
| NSMNP-0250 | In distribution | |
| 71-1000BRN | In distribution | |
| 71-8013 | In distribution | |
| 30-4070 | In distribution | |
| 71-7101 | In distribution | |
| 71-8012 | In distribution | |
| 71-1130 | In distribution | |
| 71-6517 | In distribution | |
| 71-1112 | In distribution | |
| 71-3005 | In distribution | |
| 71-2043 | In distribution | |
| 71-8002 | In distribution | |
| 71-1177 | In distribution | |
| 71-6510 | In distribution | |
| 5036-00 | In distribution | |
| 71-3012 | In distribution | |
| V71-9101 | In distribution | |
| 71-9200 | In distribution | |
| 30-I60C | In distribution | |
| 30-I60B | In distribution | |
| 71-3004 | In distribution | |
| 32-2045 | In distribution | |
| 71-1107P | In distribution | |
| NP-1006 | In distribution | |
| 71-9302 | In distribution | |
| NP-ST0250 | In distribution | |
| 71-1196 | In distribution | |
| 71-9107 | In distribution | |
| 71-1800DSB | In distribution | |
| 71-1800BR | In distribution | |
| 71-2065 | In distribution | |
| 30-4068 | In distribution | |
| 71-3200BRB | In distribution | |
| V71-3001 | In distribution | |
| 71-3102 | In distribution | |
| 71-1000BRB-C | In distribution | |
| 71-3011 | In distribution | |
| 71-3002 | In distribution | |
| 71-2054 | In distribution | |
| PHESL-1000B | In distribution | |
| NP-1007 | In distribution | |
| NP-1000 | In distribution | |
| 71-6516 | In distribution | |
| 71-9301 | In distribution | |
| 71-1105 | In distribution | |
| 71-1126 | In distribution | |
| 71-6526 | In distribution | |
| 71-9204 | In distribution | |
| 6036-SK | In distribution | |
| 30-6008 | In distribution | |
| 71-9104 | In distribution | |
| 71-3006 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pleur-Evac | Teleflex Medical LLC | 58 |
| Bemis | Bemis Manufacturing Co. | 41 |
| Suction Liner | Shijiazhuang Yuanding Medical Device Co., Ltd. | 40 |
| Medline | Medline Industries, Inc. | 26 |
| Allied Medical LLC | Allied Medical LLC | 25 |
| Suction Liner System | Shijiazhuang Yuanding Medical Device Co., Ltd. | 20 |
| Thora-Vent Thoracic Vent | Uresil, LLC | 16 |
| Medline Industries, Inc. | Medline Industries, Inc. | 15 |
| Bottle, Collection, Vacuum | Carilex Medical, Inc. | 13 |
| Ocean | Atrium Medical Corporation | 13 |
| McKesson | Mckesson Medical-Surgical Inc. | 13 |
| Grownsy | Oak Tech LLC | 11 |
Showing 12 of 216. All products under Bottle, Collection, Vacuum
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Deroyal Industries, Inc. | UDI-DI | 2023-02-09 | Class II | Process control | The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and thus, it does not create and hold vacuum. | 27,200 devices |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-08-22 | Class II | Process control | These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition. | 5112 units | 2015-04-15 |
| 2014-08-22 | Class II | Process control | These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition. | 13,900 units | 2015-04-15 |
| 2010-07-01 | Not classified | Other | Suction canisters may crack during use | 2012-04-10 |
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.