Primary Device ID | M535FW3010 |
NIH Device Record Key | 78d56dfe-47fd-43aa-9fd5-46afb3363ecb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EXPRESS FLUID WARMER |
Version Model Number | FW-301 |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M535FW3010 [Primary] |
FLA | Monitor, Temperature, Dialysis |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2022-03-22 |
Device Publish Date | 2015-09-01 |
M535FW301A0 | FW-301-A |
M535FW3010 | FW-301 |
M535FW300WW0 | FW-300-WW |
M535FW300A0 | FW-300-A |
M535FW3000 | FW-300 |
M535FW300D0 | FW-300-D |