FDA UDI
Not in Commercial Distribution
🇺🇸 United States
H2H Substitution Filter
DI: 00896241002077
·
Model: 70-6828
·
NEPHROS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- H2H Substitution Filter
- Primary DI
- 00896241002077
- Version / Model
- 70-6828
- Company Name
- NEPHROS, INC.
- Labeler DUNS
- 120664557
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2021-09-17
- Public Version Status
- Update
- Public Device Record Key
- 225b8689-3a8b-449d-9f69-ad10415b37d7
- Distribution End Date
- 2021-09-16
Device Description
H2H Substitution Filter and packaging information
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
- No
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 |
|---|---|---|---|---|
| 47334 | Haemodialysis system dialysate pyrogen-filtration set | A collection of sterile devices designed to be used with a haemodialysis system for on-line filtration of the dialysate to remove bacteria and endotoxins during haemodialysis. This purified (filtered) dialysate is used for the replacement fluid (substitution solution). It includes tubing with an integrated filter(s), and typically connectors (e.g., Luer-lock) and a sampling port. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10896241002074 | GS1 | Carton | 5 | Not in Commercial Distribution | 2021-09-16 |
| Primary | 00896241002077 | GS1 | ||||
| Package | 20896241002071 | GS1 | Box | 20 | Not in Commercial Distribution | 2021-09-16 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112314 | 000 |