Primary Device ID | M535NX200011A0 |
NIH Device Record Key | 11a17780-1543-42a2-b498-ef03383031a7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PUREFLOW SL |
Version Model Number | NX2000-11-A |
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 | |
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 |
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 |
---|---|
HIBCC | M535NX200011A0 [Primary] |
FKR | Subsystem, Proportioning |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-29 |
Device Publish Date | 2023-06-21 |
M535NX200011A0 | NX2000-11-A |
M535NX200010D0 | NX2000-10-D |