Dispensing Pin
Standard Spike Dispensing Pin with SAFSITE® Valve with Luer Slip Connector
8manufacturers in China registered for this device type
10catalogue numbers in this listing
9510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (3), Jiangsu (3), Hong Kong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Ming FAI Enterprise International Co., Ltd. | Kowloon | Hong Kong | Exporter | 18 |
| Zhejiang Medtec Medical devices Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 10 |
| Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
Record
| Listed by | B. Braun Medical Inc., United States |
|---|---|
| FDA product code | LHI |
| Device type | Set, I.V. Fluid Transfer |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2020-11-06 (version 8) |
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 |
| Distribution end date | 2019-10-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 412021 | 50 | In distribution | |
| 412005 | 50 | In distribution | |
| 412002 | 50 | In distribution | |
| 412720 | 50 | In distribution | |
| 412022 | 50 | In distribution | |
| 413501 | 50 | In distribution | |
| 412008 | 50 | In distribution | |
| 412023 | 50 | In distribution | |
| 412013 | 50 | In distribution | |
| 412172 | 50 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kenaflexx | Kentron Healthcare, Inc. | 49 |
| Set, I.V. Fluid Transfer | Mps Medical, Inc. | 27 |
| Vial Adaptor | West Pharma. Services IL, Ltd. | 26 |
| Vial Adapter | West Pharma. Services IL, Ltd. | 22 |
| Extension SET | MPS Pharma & Medical, Inc. | 19 |
| Vial Adapter Medic’up | Union Plastic | 17 |
| Exactamix | Baxter Healthcare Corporation | 16 |
| Mix2Vial Transfer Device | West Pharma. Services IL, Ltd. | 15 |
| Arisure | Yukon Medical, LLC | 13 |
| ViaLok | Yukon Medical, LLC | 12 |
| ICU Medical | ICU Medical, Inc | 12 |
| Codan | Codan US Corp. | 10 |
Showing 12 of 233. All products under Set, I.V. Fluid Transfer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201469 | 2020-12-09 |
| K151423 | 2016-02-19 |
| K150787 | 2015-12-02 |
| K120150 | 2012-05-24 |
| K100640 | 2010-07-22 |
| K090905 | 2009-04-27 |
| K041222 | 2004-10-14 |
| K970359 | 1997-03-18 |
| K955398 | 1996-04-04 |
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 | Closed |
|---|---|---|---|---|---|---|---|
| B. Braun US Device Manufacturing LLC | UDI-DI | 2022-01-31 | Class II | Under Investigation by firm | This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to the | 15,550 ea (US); 900 ea (OUS) | 2024-04-29 |
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.