FDA UDI
In Commercial Distribution
🇺🇸 United States
NXView Touch Monitor
DI: M535NX3302A0
·
Model: NX3302-A
·
NXSTAGE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NXView Touch Monitor
- Primary DI
- M535NX3302A0
- Version / Model
- NX3302-A
- Catalog Number
- NX3302-A
- Company Name
- NXSTAGE MEDICAL, INC.
- Labeler DUNS
- 088013219
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-11
- Public Version
- 1
- Public Version Date
- 2020-03-19
- Public Version Status
- New
- Public Device Record Key
- 6a432245-d75f-4294-9caf-15ef20ed0939
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | Gastroenterology, Urology | 876.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58131 | Haemodialysis system, institutional/home-use | An assembly of mains electricity (AC-powered) devices designed to perform haemodialysis, a treatment whereby extracorporeal blood is passed through a filter to allow for the removal of toxins and/or the replacement of electrolytes. The system functions with dialysate solution and a haemodialysis dialyser (haemodialyzer) for the transfer of substances by diffusion, osmosis and ultrafiltration. The system typically includes a pump and tubing to circulate blood through the haemodialysis dialyser, a solution mixer to prepare the dialysate, a monitor with system controls, and other dedicated components. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M535NX3302A0 | HIBCC |
Customer Contacts
- Phone
- 1-866-697-8243
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 93 Percent (%) Relative Humidity