FDA UDI In Commercial Distribution 🇺🇸 United States

NXSTAGE CARTRIDGE EXPRESS

DI: M535CAR1720 · Model: CAR-172 · NXSTAGE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
NXSTAGE CARTRIDGE EXPRESS
Primary DI
M535CAR1720
Version / Model
CAR-172
Company Name
NXSTAGE MEDICAL, INC.
Labeler DUNS
088013219
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-09-01
Public Version
3
Public Version Date
2018-11-08
Public Version Status
Update
Public Device Record Key
6ebcf49b-088d-4d5b-97ef-e16914026fcc

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

GMDN Terms

Code Name
61674 Haemodialysis/haemofiltration system component set

Identifiers

Type ID
Package M535CAR1725
Primary M535CAR1720

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
15 – 30 Degrees Celsius