DeRoyal
Tubing,Insuf w/.1 Micr Filter Colored Tube
12manufacturers in China registered for this device type
34catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (2), Guangdong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Smartdata Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 11 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
| Anhui Shiyin Photoelectric Instrument Co., Ltd. | Suzhou | Anhui | Specification developer | 18 |
| Zhejiang Shuyou Surgical Instrument Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| BIO Protech Yantai Inc | Yantai | Shandong | Manufacturer | 12 |
| Changzhou Rongxin Medicine Minimal Invasion Technology Co., Ltd. | Jintan | Jiangsu | Contract manufacturer | 10 |
| Unimicro Medical Systems (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Heng Chuang Plastic & Metal Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | NKC |
| Device type | Tubing/Tubing With Filter, Insufflation, Laparoscopic |
| Device class | Class 1 |
| Regulation | 21 CFR 884.1730 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-28 |
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, manufacturing date |
| Packaging | Case of 20, case of 100, box of 50, box of 10, box of 20, case of 500 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 28-0211NS | In distribution | |
| 28-0203 | In distribution | |
| 28-0213 | In distribution | |
| 28-0202 | In distribution | |
| 28-0212 | In distribution | |
| 28-0226 | In distribution | |
| 28-0209 | In distribution | |
| 28-0210NS | In distribution | |
| 28-0209NS | In distribution | |
| 28-0201NS | In distribution | |
| 28-0205NS | In distribution | |
| 28-0212HNS | In distribution | |
| 28-0231NS | In distribution | |
| 28-0212NS | In distribution | |
| V28-0210 | In distribution | |
| 28-0216 | In distribution | |
| 28-0225 | In distribution | |
| 28-0216NS | In distribution | |
| 28-0207 | In distribution | |
| 28-0223B | In distribution | |
| 28-0230NS | In distribution | |
| 28-0210 | In distribution | |
| 28-0217 | In distribution | |
| V28-0201 | In distribution | |
| 28-0213NS | In distribution | |
| 28-0201 | In distribution | |
| V28-0207 | In distribution | |
| 28-0211 | In distribution | |
| 28-0223 | In distribution | |
| 28-0207NS | In distribution | |
| 28-0214 | In distribution | |
| 28-0224 | In distribution | |
| 17-9778 | In distribution | |
| 28-0212H | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | Karl Storz GmbH & Co. KG | 18 |
| JosNoe Medical Inc | JosNoe Medical Inc | 15 |
| Cardinal Health | Cardinal Health 200, LLC | 12 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 12 |
| Surgical Direct | Surgical Direct, Inc. | 11 |
| Tech-Medical Services | Techmedical Services, Inc. | 10 |
| V. Mueller | Steris Corporation | 7 |
| MED-RX | Canadian Hospital Specialties Ltd. | 6 |
| CHS | Deroyal Industries, Inc. | 5 |
| Medline Industries, Inc. | Medline Industries, Inc. | 5 |
| MediChoice | Owens & Minor Distribution, Inc. | 5 |
| Key Surgical | Canadian Hospital Specialties Ltd. | 5 |
Showing 12 of 75. All products under Tubing/Tubing With Filter, Insufflation, Laparoscopic
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2013-07-15 | Class II | Packaging process control | DeRoyal Industries is recalling their product Insufflation Tubing Sets due to materials incompatibility which could possibly result in occlusion at or near the filter housing which could prevent the flow of gas through the device. | 506,632 sets in US; 17,854 sets International | 2015-05-20 |
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.