| Primary Device ID | M535SLE3000M30955 |
| NIH Device Record Key | b9578893-5ca7-4839-9b2f-cef9e9ecd76b |
| Commercial Distribution Discontinuation | 2021-07-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Streamline Express Dialyzer with Pre-attached Tubing Set For Fresenius 2008 Seri |
| Version Model Number | SLE-3000M3095 |
| Company DUNS | 061310132 |
| Company Name | MEDISYSTEMS 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 | true |
| 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 | |
| Phone | 1-866-697-8243 |
| info@nxstage.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M535SLE3000M30950 [Primary] |
| HIBCC | M535SLE3000M30955 [Package] Contains: M535SLE3000M30950 Package: [15 Units] Discontinued: 2021-07-31 Not 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 | 4 |
| Public Version Date | 2021-11-18 |
| Device Publish Date | 2015-09-01 |
| M535M820062 - ViraGuard Viral Blocking Patient Transducer Protector | 2025-08-07 |
| M535SLE3000M30955 - Streamline Express Dialyzer with Pre-attached Tubing Set For Fresenius 2008 Seri | 2021-11-18 |
| M535SLE3000M30955 - Streamline Express Dialyzer with Pre-attached Tubing Set For Fresenius 2008 Seri | 2021-11-18 |
| M535SLE3010M30965 - Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog Serie | 2021-11-18 |
| M535SLE3011M30985 - Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog Serie | 2021-11-18 |
| M535M850075 - Medisystems Medic Anti-stick Needle/Connector | 2020-10-20 |
| 10842289100517 - Medisystems Button Hole Needle Set with SteriPick | 2020-06-30 |
| 10842289100524 - Medisystems Button Hole Needle Set with SteriPick | 2020-06-30 |
| 10842289100531 - Medisystems Button Hole Needle Set with SteriPick | 2020-06-30 |