VersiHD
GUDID M535NX100010B0
NXSTAGE MEDICAL, INC.
Haemodialysis system, institutional/home-use Haemodialysis system, institutional/home-use Haemodialysis system, institutional/home-use Haemodialysis system, institutional/home-use Haemodialysis system, institutional/home-use Haemodialysis system, institutional/home-use Haemodialysis system, institutional/home-use Haemodialysis system, institutional/home-use Haemodialysis system, institutional/home-use Haemodialysis system, institutional/home-use Haemodialysis system, institutional/home-use Haemodialysis system, institutional/home-use Haemodialysis system, institutional/home-use Haemodialysis system, institutional/home-use Haemodialysis system, institutional/home-use Haemodialysis system, institutional/home-use| Primary Device ID | M535NX100010B0 |
| NIH Device Record Key | f4c13ba2-6aa8-4359-941c-b4103535aebc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VersiHD |
| Version Model Number | NX1000-10-B |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M535NX100010B0 [Primary] |
FDA Product Code
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-16 |
| Device Publish Date | 2021-12-08 |
On-Brand Devices [VersiHD]
| M535NX100010B0 | NX1000-10-B |
| M535NX100010D0 | NX1000-10-D |
Trademark Results [VersiHD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERSIHD 87664624 not registered Dead/Abandoned |
NxStage Medical, Inc. 2017-10-30 |
 VERSIHD 85481338 4310050 Live/Registered |
AirBorn, Inc. 2011-11-28 |
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