FDA UDI
In Commercial Distribution
🇺🇸 United States
Molded Products, Inc.
DI: B144MPC7201
·
Model: MPC-720
·
MOLDED PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
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Basic Information
- Brand Name
- Molded Products, Inc.
- Primary DI
- B144MPC7201
- Version / Model
- MPC-720
- Catalog Number
- MPC-720
- Company Name
- MOLDED PRODUCTS, INC.
- Labeler DUNS
- 157506015
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- 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
- 7ca77291-a1fb-4559-bc30-8a02ff4c32c2
Device Description
Double Line 10-7/8" Length Adapter, Re-Use
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| FID | Tubing, Dialysate | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47071 | Hollow-fibre haemodialysis dialyser, reusable | 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-patient, reusable device after high-level disinfection. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B144MPC7203 | HIBCC | Case | 20 | In Commercial Distribution | |
| Primary | B144MPC7201 | HIBCC | ||||
| Unit of Use | B144MPC7200 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K010712 | 000 |