| Primary Device ID | 04987488104146 |
| NIH Device Record Key | f3298237-e8ee-458a-9de1-21b0d9021ec0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INTERMITTENT INJECTION SITE |
| Version Model Number | INT-01 |
| Catalog Number | INT-01 |
| Company DUNS | 690625850 |
| Company Name | SB-KAWASUMI LABORATORIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 04987488104139 - K-Shield Advantage Blood Drawing Kit | 2025-01-01 The Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile transfer set designed for vascular access for blo |
| 04987488104146 - INTERMITTENT INJECTION SITE | 2024-12-16The product is a simple injection/aspiration port which will be sold by itself. It terminates in a male luer taper which can be mated with any femail luer tapered lumen in a device, such as a catheter, communicating with blood or other body fluids. The port occludes the lumen of the catheter or other device. It also provides a latex septum for injection of fluids, including medication, or for aspiration of blood or fluids for testing, ETC. The septum is no-slitted. The Product is discarded when the main device is changed.
This product comes with a luer protector cap which is removed and discarded before attaching the port to the catheter or device.
This product is not specifically designed for use in hemodialysis systems. |
| 04987488104146 - INTERMITTENT INJECTION SITE | 2024-12-16 The product is a simple injection/aspiration port which will be sold by itself. It terminates in a male luer taper which can be |
| 04987488102241 - PORT ACCESS INFUSION SET | 2024-04-22 Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through |
| 04987488102258 - PORT ACCESS INFUSION SET | 2024-04-22 Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through |
| 04987488102265 - PORT ACCESS INFUSION SET | 2024-04-22 Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through |
| 04987488102272 - PORT ACCESS INFUSION SET | 2024-04-22 Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through |
| 04987488102289 - PORT ACCESS INFUSION SET | 2024-04-22 Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through |
| 04987488102296 - PORT ACCESS INFUSION SET | 2024-04-22 Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through |