FDA UDI
In Commercial Distribution
🇺🇸 United States
Molded Products, Inc.
DI: B144MPC85TE2
·
Model: MPC-85TE
·
MOLDED PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
125
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Basic Information
- Brand Name
- Molded Products, Inc.
- Primary DI
- B144MPC85TE2
- Version / Model
- MPC-85TE
- Catalog Number
- MPC-85TE
- Company Name
- MOLDED PRODUCTS, INC.
- Labeler DUNS
- 157506015
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 125
- Record Status
- Published
- Publish Date
- 2016-12-16
- Public Version
- 4
- Public Version Date
- 2025-08-07
- Public Version Status
- Update
- Public Device Record Key
- 2d26f2b0-1c05-4be3-8a21-75452f1b4494
Device Description
DIALYSIS TRANSDUCER PROTECTOR - Tamper Evident Packaging
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FIB | Protector, Transducer, Dialysis | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32109 | Haemodialysis system transducer protector | A device designed to protect a haemodialysis system pressure monitor from contamination and to help maintain the sterility of the blood tubing fluid pathway. It is typically attached between the blood tubing set and the pressure monitor and typically consists of plastic housing that contains a hydrophobic filter with a reference pore size (e.g., 1 to 2 microns) that helps prevent transfer of by viruses, bacteria, and particulate matter, while preventing the flow of fluids, to the pressure monitor. It may feature tubing and a male Luer lock designed to facilitate replacement of a contaminated transducer protector via a secondary connection on the pressure monitor. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B144MPC85TE3 | HIBCC | Case | 22 | In Commercial Distribution | |
| Primary | B144MPC85TE2 | HIBCC | ||||
| Unit of Use | B144MPC85TE0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K925978 | 000 |