| Primary Device ID | 10842289101262 |
| NIH Device Record Key | b5937b9c-dbd9-4f9d-b5de-f2d68cb6251c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NxStage PureFlow-B Solution |
| Version Model Number | RFP-401-BB |
| Company DUNS | 088013219 |
| Company Name | NXSTAGE MEDICAL, INC. |
| 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 | 1-866-697-8243 |
| info@nxstage.com |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842289101265 [Primary] |
| GS1 | 10842289101262 [Package] Contains: 00842289101265 Package: Shipping Box [2 Units] In Commercial Distribution |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) |
| 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 | 2017-04-11 |
| 10842289101262 | RFP-401-BB |
| 10842289101255 | RFP-400-BB |