| Primary Device ID | 40383790004419 |
| NIH Device Record Key | 44f7b82d-c1b5-4dcb-8c1a-01d4726fd212 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NIPRO Cellentia™-H Hemodialyzer |
| Version Model Number | Cellentia™-21H |
| Catalog Number | DD+CT21H |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00383790004411 [Primary] |
| GS1 | 40383790004419 [Package] Contains: 00383790004411 Package: [24 Units] In Commercial Distribution |
| KDI | Dialyzer, high permeability with or without sealed dialysate system |
| 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 | 2017-06-15 |
| 40383790004419 | CELLULOSE TRIACETATE HEMODIALYZER 2.1m² / Max.TMP 66kPa (500mmHg) |
| 40383790004402 | CELLULOSE TRIACETATE HEMODIALYZER 1.9m² / Max.TMP 66kPa (500mmHg) |
| 40383790004396 | CELLULOSE TRIACETATE HEMODIALYZER 1.7m² / Max.TMP 66kPa (500mmHg) |
| 40383790004389 | CELLULOSE TRIACETATE HEMODIALYZER 1.5m² / Max.TMP 66kPa (500mmHg) |