| Primary Device ID | 00383790008884 |
| NIH Device Record Key | bcea4f7c-4627-45c2-8989-d31103b446d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SafeTouch™ PSV Winged Infusion Set |
| Version Model Number | 85951041 |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00383790008884 [Primary] |
| FOZ | Catheter, intravascular, therapeutic, short-term less than 30 days |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-10 |
| Device Publish Date | 2018-08-10 |
| 00383790008884 | 85951041 |
| 00383790004374 | 85516639 |