DeRoyal
Fletcher Allen Healthcare Neuro Kit
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (3), Hubei (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| Zibo Qichuang Medical Products Co., Ltd. | Zibo | Shandong | Manufacturer | 27 |
| Yafho BIO-Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 14 |
| Xiamen ANK Hygiene Care Product Co., Ltd. | Xiamen | Fujian | Manufacturer | 11 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | LRS |
| Device type | I.V. Start Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-12 |
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 | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 25 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 77-400788 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 1,066 |
| Centurion | Centurion Medical Products Corporation | 886 |
| Medline Industries, Inc. | Medline Industries, Inc. | 740 |
| Medline | Medline Industries, Inc. | 621 |
| Medical Action Industries | Medical Action Industries, Inc. | 512 |
| Curaplex | Bound Tree Medical, LLC | 149 |
| Motion Medical Distributing | Haslam Medical, Inc. | 118 |
| LSL Healthcare | Lsl Industries, Inc. | 83 |
| Vygon | Vygon Corp. | 76 |
| Trinity Sterile, Inc. | Trinity Sterile, Inc. | 63 |
| MediChoice | Owens & Minor Distribution, Inc. | 46 |
| McKesson | Mckesson Medical-Surgical Inc. | 21 |
Showing 12 of 58. All products under I.V. Start Kit
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.