NXSTAGE TPE CARTRIDGE

GUDID M535CAR510B5

Apheresis system tubing set

Primary Device ID	M535CAR510B5
NIH Device Record Key	484df07a-5803-492d-b850-d937e6066533
Commercial Distribution Discontinuation	2023-06-19
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	NXSTAGE TPE CARTRIDGE
Version Model Number	CAR-510-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	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

Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius

Device Issuing Agency	Device ID
HIBCC	M535CAR510B0 [Primary]
HIBCC	M535CAR510B5 [Package] Contains: M535CAR510B0 Package: [6 Units] Discontinued: 2023-06-19 Not in Commercial Distribution

KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System

Steralize Prior To Use	false
Device Is Sterile	true