| Primary Device ID | 00383790004367 |
| NIH Device Record Key | 07e0c0a4-1654-4a41-b69a-f34d8df16245 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SafeTouch™ PSV Winged Infusion Set with Filter |
| Version Model Number | 85516620 |
| Company DUNS | 797372554 |
| Company Name | NIPRO MEDICAL CORPORATION |
| 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 | false |
| 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 |
| Phone | +1(908) 393-7030 |
| info@nipromed.com | |
| Phone | +1(908) 393-7030 |
| info@nipromed.com |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00383790004367 [Primary] |
| FOZ | Catheter,intravascular,therapeutic,short-term less than 30 days |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-03-08 |
| 40383790011875 - SLIMLINE™ BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET | 2025-06-09 Slimline Blood Tubing for Fresenius 2008H, K, K2, T |
| 40383790011882 - NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET | 2025-06-09 Blood Tubing Set for B Braun Dialog |
| 40383790011899 - NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET | 2025-06-09 Blood Tubing Set for Fresenius 2008 |
| 40383790011905 - NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET | 2025-06-09 Blood Tubing Set for Fresenius 2008 |
| 40383790011912 - Nipro Set Blood Tubing Set | 2025-06-09 Blood Tubing Set for SURDIAL DX Hemodialysis System |
| 10383790011935 - NIPRO SYRINGE | 2025-06-09 Syringe 10mL Luer Lock |
| 10383790011942 - NIPRO SYRINGE | 2025-06-09 Syringe with Needle (20x1") 10mL, luer lock |
| 10383790011959 - NIPRO SYRINGE | 2025-06-09 Syringe 10mL Luer Lock with Needle 20G x 1-1/2" |