| Primary Device ID | 40383790007069 |
| NIH Device Record Key | 612b491e-e042-4a60-a5ac-15d1615d212f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NIPRO ELISIO™ -H HEMODIALYZER |
| Version Model Number | ELISIO™-09H |
| Catalog Number | DD+ELISIO-09H |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00383790007061 [Primary] |
| GS1 | 40383790007069 [Package] Contains: 00383790007061 Package: Case [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 | 2015-09-16 |
| 40383790007137 | Surface area 2.5m² Max.TMP:66kPa(500mmHg) |
| 40383790007120 | Surface area 2.1m² Max.TMP:66kPa(500mmHg) |
| 40383790007113 | Surface area 1.9m² Max.TMP:66kPa(500mmHg) |
| 40383790007106 | Surface area 1.7m² Max.TMP:66kPa(500mmHg) |
| 40383790007090 | Surface area 1.5m² Max.TMP:66kPa(500mmHg) |
| 40383790007083 | Surface area 1.3m² Max.TMP:66kPa(500mmHg) |
| 40383790007076 | Surface area 1.1m² Max.TMP:66kPa(500mmHg) |
| 40383790007069 | Surface area 0.9m² Max.TMP:66kPa(500mmHg) |