Cardinal Health
Ultrasound Guided IV Start KIT
7manufacturers in China registered for this device type
1,066catalogue numbers in this listing
3recalls on this code
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 | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | LRS |
| Device type | I.V. Start Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-07-18 |
| Record revised | 2026-03-20 (version 7) |
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, manufacturing date |
| Storage | Storage environment temperature up to 40 °C |
| Packaging | Case of 100, case of 50, case of 30, case of 238, case of 40, case of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-5590B | In distribution | |
| IVS534227B | In distribution | |
| 01-5061A | In distribution | |
| 01B8060C | In distribution | |
| 01-5384A | In distribution | |
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| IVS211334A | In distribution | |
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Medline | Centurion Medical Products Corporation | 18 |
Showing 12 of 58. All products under I.V. Start Kit
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cardinal Health 200, LLC | UDI-DI | 2022-11-18 | Class II | Nonconforming Material/Component | Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity | 4560 EA |
| Cardinal Health 200, LLC | UDI-DI | 2022-11-18 | Class II | Nonconforming Material/Component | Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity | 36 EA |
| Cardinal Health 200, LLC | UDI-DI | 2022-11-18 | Class II | Nonconforming Material/Component | Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity | 31,300 EA |
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.