FDA UDI
In Commercial Distribution
🇺🇸 United States
TQE Plus Endotoxin 10" Filter Flat 222 Head
DI: 00868277000440
·
Model: TQE0.005-10HP3E
·
NEPHROS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- TQE Plus Endotoxin 10" Filter Flat 222 Head
- Primary DI
- 00868277000440
- Version / Model
- TQE0.005-10HP3E
- Company Name
- NEPHROS, INC.
- Labeler DUNS
- 120664557
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-16
- Public Version
- 2
- Public Version Date
- 2024-02-14
- Public Version Status
- Update
- Public Device Record Key
- 69ac3265-a05b-4211-8580-b59391d60ac7
Device Description
The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
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 |
|---|---|---|---|---|---|---|
| Package | 10868277000447 | GS1 | Filter Box | 1 | In Commercial Distribution | |
| Primary | 00868277000440 | GS1 | ||||
| Package | 20868277000444 | GS1 | Carton Box | 30 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161304 | 000 |