| Primary Device ID | 40383790005737 | 
| NIH Device Record Key | a8dc3dc3-8311-4e82-bcd8-831f08eaaaa7 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | NIPRO SOLUTION INFUSION SET | 
| Version Model Number | IS-01-A/A-21GS | 
| 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 | 00383790005739 [Primary] | 
| GS1 | 10383790005736 [Package] Contains: 00383790005739 Package: [100 Units] In Commercial Distribution | 
| GS1 | 40383790005737 [Package] Contains: 10383790005736 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 |