Primary Device ID | 00842289104044 |
NIH Device Record Key | bb3ad05d-0618-4ce3-b273-665f7d5fb546 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | VersiHD with GuideMe Software |
Version Model Number | NX1000-16-H |
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 |
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 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00842289104044 [Primary] |
KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-10-01 |
Device Publish Date | 2025-09-23 |
M535NX100016F0 | NX1000-16-F |
M535NX100010F0 | NX1000-10-F |
M535NX100010E0 | NX1000-10-E |
00842289104051 | NX1000-10-H |
00842289104044 | NX1000-16-H |
00842289103894 | NX1000-10-E |