FDA UDI In Commercial Distribution 🇺🇸 United States

Water Purification System for Hemodialysis

DI: 00860006352127 · Model: Complete System · Nelson Environmental Technologies Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Water Purification System for Hemodialysis
Primary DI
00860006352127
Version / Model
Complete System
Company Name
Nelson Environmental Technologies Inc
Labeler DUNS
835316464
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-08-17
Public Version
1
Public Version Date
2023-08-25
Public Version Status
New
Public Device Record Key
8a21db4a-5c67-42a0-87e7-8da6994ea1b1

Device Description

Nelson Water System's Water Purification System for Hemodialysis is intended to be used for purifying the water used in hemodialysis treatment. It removes organic, inorganic, and microbial contaminants from the water.

Device Characteristics

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FIP Subsystem, Water Purification

GMDN Terms

Code Name
44344 Combination water purification system

Identifiers

Type ID
Primary 00860006352127