MarCor ENX Hollow Fiber Capsule UltraFilter
Basic Information
- Brand Name
- MarCor ENX Hollow Fiber Capsule UltraFilter
- Primary DI
- 00896241002732
- Version / Model
- W2T912244
- Catalog Number
- 70-0251M
- Company Name
- NEPHROS, INC.
- Labeler DUNS
- 120664557
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-18
- Public Version
- 5
- Public Version Date
- 2024-02-14
- Public Version Status
- Update
- Public Device Record Key
- aae08fad-b49c-4584-9557-23efbbaa7277
Device Description
The MarCor ENX Hollow Fiber Capsule UltraFilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.). Use: The device is intended for long term continuous use. Once it completes its useful life, the filter should be replaced and discarded. Do not attempt to sterilize or reuse it. CONTRAINDICATIONS Medical: While the MarCor ENX produces ultrapure water, the water is not intended to be used in medical applications where USP sterile water is normally used. Chemical: The MarCor ENX retains biological contaminants. To obtain chemically pure water it is necessary to use the filter in conjunction with other devices such as DI beds or RO systems.
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
- No
- 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
- Yes
- Sterilization Methods
- Liquid Chemical
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FIP | Subsystem, Water Purification | Gastroenterology, Urology | 876.5665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47739 | Haemodialysis system dialysate pyrogen filter | A sterile device designed to be used with a haemodialysis system for filtration of dialysate during haemodialysis to remove bacteria and endotoxins and produce purified dialysate for the procedure. It may perform secondary safety filtering to prepare on-line substitution solution that can be infused into the patient to compensate for loss of fluid volume resulting from haemodialysis. It typically consists of a plastic housing, containing a hollow fibre membrane, with appropriate connectors at either end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00896241002732 | GS1 | ||||
| Package | 10896241002739 | GS1 | Filter Box | 1 | In Commercial Distribution | |
| Package | 20896241002736 | GS1 | Carton Box | 10 | In Commercial Distribution |