| Primary Device ID | 10383790003374 |
| NIH Device Record Key | 64055a12-15a0-4b6f-9f3f-f442a050d31a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NIPRO SOLUTION INFUSION SET |
| Version Model Number | IS-01-A/A-21G/BL |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(908) 393-7030 |
| info@nipromed.com | |
| Phone | +1(908) 393-7030 |
| info@nipromed.com | |
| Phone | +1(908) 393-7030 |
| info@nipromed.com | |
| Phone | +1(908) 393-7030 |
| info@nipromed.com | |
| Phone | +1(908) 393-7030 |
| info@nipromed.com | |
| Phone | +1(908) 393-7030 |
| info@nipromed.com | |
| Phone | +1(908) 393-7030 |
| info@nipromed.com | |
| Phone | +1(908) 393-7030 |
| info@nipromed.com | |
| Phone | +1(908) 393-7030 |
| info@nipromed.com | |
| Phone | +1(908) 393-7030 |
| info@nipromed.com | |
| Phone | +1(908) 393-7030 |
| info@nipromed.com | |
| Phone | +1(908) 393-7030 |
| info@nipromed.com | |
| Phone | +1(908) 393-7030 |
| info@nipromed.com | |
| Phone | +1(908) 393-7030 |
| info@nipromed.com | |
| Phone | +1(908) 393-7030 |
| info@nipromed.com | |
| Phone | +1(908) 393-7030 |
| info@nipromed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00383790003377 [Primary] |
| GS1 | 10383790003374 [Package] Contains: 00383790003377 Package: [100 Units] In Commercial Distribution |
| GS1 | 40383790003375 [Package] Package: [4 Units] In Commercial Distribution |
| FPA | Set, administration, intravascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2016-09-16 |
| 10383790005743 | IS-01-A/A-21G/NV |
| 40383790005737 | IS-01-A/A-21GS |
| 10383790003374 | IS-01-A/A-21G/BL |
| 10383790003367 | IS-01-A/A-21G |