FDA UDI
Not in Commercial Distribution
🇺🇸 United States
S100 Handheld quick connect
DI: 00896241002589
·
Model: 70-0287
·
NEPHROS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- S100 Handheld quick connect
- Primary DI
- 00896241002589
- Version / Model
- 70-0287
- Company Name
- NEPHROS, INC.
- Labeler DUNS
- 120664557
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 5
- Public Version Date
- 2021-09-17
- Public Version Status
- Update
- Public Device Record Key
- c1a9b028-45a6-4f2d-b5d2-1e3108877652
- Distribution End Date
- 2021-09-16
Device Description
S100 Handheld quick connect and packaging information
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| NHV | System, Water Purification, General Medical Use | Gastroenterology, Urology | 876.5665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61138 | Legionella water purification filter, non-sterile | A non-sterile device intended to remove Legionella bacteria from flowing water to reduce the risk of Legionella contamination during body washing for hygiene; it is not intended for medical washing/irrigation and is not intended for general microbial filtration. It typically consists of a plastic housing with a connector attached to the water source [e.g., a tap (faucet)] and a filtering membrane [e.g., made of polyethersulfone (PES)]; it may include a distal shower rose/directing nozzle. This is a disposable device not intended to be reprocessed, which has a multiple-patient use application (reusable). | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10896241002586 | GS1 | carton | 6 | Not in Commercial Distribution | 2021-09-16 |
| Primary | 00896241002589 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153084 | 000 |