| Primary Device ID | 00646311550058 |
| NIH Device Record Key | 10522861-a316-4ae1-af4b-bc42420164b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PORT ACCESS INFUSION SET |
| Version Model Number | PI01Y91 |
| Company DUNS | 690625850 |
| Company Name | KAWASUMI LABORATORIES, INCORPORATED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Needle Gauge | 19 Gauge |
| Needle Gauge | 19 Gauge |
| Needle Gauge | 19 Gauge |
| Needle Gauge | 19 Gauge |
| Needle Gauge | 19 Gauge |
| Needle Gauge | 19 Gauge |
| Needle Gauge | 19 Gauge |
| Needle Gauge | 19 Gauge |
| Needle Gauge | 19 Gauge |
| Needle Gauge | 19 Gauge |
| Needle Gauge | 19 Gauge |
| Needle Gauge | 19 Gauge |
| Needle Gauge | 19 Gauge |
| Needle Gauge | 19 Gauge |
| Needle Gauge | 19 Gauge |
| Needle Gauge | 19 Gauge |
| Needle Gauge | 19 Gauge |
| Needle Gauge | 19 Gauge |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00646311550058 [Primary] |
| FRN | Pump, Infusion |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2016-09-20 |