FDA UDI
In Commercial Distribution
🇺🇸 United States
Bicarbonate Spare Connectors Set
DI: 05060497260153
·
Model: SC-14918
·
QUANTA DIALYSIS TECHNOLOGIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bicarbonate Spare Connectors Set
- Primary DI
- 05060497260153
- Version / Model
- SC-14918
- Company Name
- QUANTA DIALYSIS TECHNOLOGIES LIMITED
- Labeler DUNS
- 211298693
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-13
- Public Version
- 1
- Public Version Date
- 2023-07-21
- Public Version Status
- New
- Public Device Record Key
- 9739c6c4-ce16-4728-8fac-d16a0e2fe1f7
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
- 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 |
|---|---|---|---|---|
| 63952 | Haemodialysis system dialysate delivery set | A collection of non-powered, non-sterile devices intended to be integrated within a haemodialysis system to allow for mixing and delivery of dialysate solution from a powered delivery unit (not included) to the dialyser (not included). The set includes mixing chambers to allow the dialysate to be mixed from a concentrate solution, pumping reservoirs designed to be compressed by an actuator(s) within the delivery unit to displace the dialysate, and an array of tubing/connectors; it is intended to be used in the home and healthcare settings. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060497260153 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222067 | 000 |