FDA UDI
In Commercial Distribution
🇺🇸 United States
Molded Products, Inc.
DI: B144MPC7281
·
Model: MPC-728
·
MOLDED PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Molded Products, Inc.
- Primary DI
- B144MPC7281
- Version / Model
- MPC-728
- Catalog Number
- MPC-728
- Company Name
- MOLDED PRODUCTS, INC.
- Labeler DUNS
- 157506015
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- 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
- 8d66956c-6d80-4694-b711-a8c9739aca29
Device Description
Dialysate Line with Flow Restrictor
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 |
|---|---|---|---|---|
| FID | Tubing, Dialysate | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58093 | Haemodialysis treatment kit | A collection of sterile and disposable/consumable devices intended to be used to prepare for and perform a haemodialysis treatment with a haemodialysis system. It typically consists of tubing, haemodialysis dialysers, dialysate concentrates, and rinsing solutions for preparation of the extracorporeal circuit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B144MPC7281 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K022068 | 000 |