| Primary Device ID | 10842289102610 |
| NIH Device Record Key | b7971279-633f-48e7-9032-13104d57efec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dialysis Priming Set |
| Version Model Number | M4-9440 |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing and excessive heat |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842289102613 [Primary] |
| GS1 | 10842289102610 [Package] Contains: 00842289102613 Package: Shipping Box [200 Units] In Commercial Distribution |
| KOC | Accessories, Blood Circuit, Hemodialysis |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-14 |
| Device Publish Date | 2020-10-06 |
| 00842289103894 - VersiHD with GuideMe Software | 2025-10-01 |
| 00842289104044 - VersiHD with GuideMe Software | 2025-10-01 |
| 00842289104051 - VersiHD with GuideMe Software | 2025-10-01 |
| M535RFP205WW5 - NxStage PureFlow Solution | 2025-07-23 |
| 00842289103870 - NXSTAGE CARTRIDGE EXPRESS | 2024-08-01 |
| 00842289103887 - NXSTAGE CARTRIDGE EXPRESS | 2024-08-01 |
| 10842289103044 - NxStage PureFlow Solution | 2024-04-04 |
| 10842289103051 - NxStage PureFlow Solution | 2024-04-04 |