FDA UDI
In Commercial Distribution
🇺🇸 United States
Molded Products, Inc.
DI: B144MPC50DVY1
·
Model: MPC-50DV-Y
·
MOLDED PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
Basic Information
- Brand Name
- Molded Products, Inc.
- Primary DI
- B144MPC50DVY1
- Version / Model
- MPC-50DV-Y
- Catalog Number
- MPC-50DV-Y
- Company Name
- MOLDED PRODUCTS, INC.
- Labeler DUNS
- 157506015
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2019-09-04
- Public Version
- 1
- Public Version Date
- 2019-09-12
- Public Version Status
- New
- Public Device Record Key
- aa72ae3d-03e8-4fd5-9a94-86dd72478b59
Device Description
Vented Dialysate Port, Storage Cap - Yellow
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FJI | Dialyzer, Capillary, Hollow Fiber | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47072 | Hollow-fibre haemodialysis dialyser, single-use | A filter that functions as an artificial kidney and typically used in a haemodialysis system to remove impurities/fluid from the blood of a patient. It typically consists of cylindrical containers with thousands of longitudinally arranged hollow-fibre capillary tubes (e.g., polymer, modified cellulose) through which the blood flows. The tube walls function as a semi-permeable membrane, permitting passage of larger molecules from the blood to the dialysate on the outside of the tubes for removal. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B144MPC50DVY3 | HIBCC | Case | 20 | In Commercial Distribution | |
| Primary | B144MPC50DVY1 | HIBCC | ||||
| Unit of Use | B144MPC50DVY0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K010366 | 000 |