FDA UDI
In Commercial Distribution
🇺🇸 United States
Molded Products, Inc.
DI: B144MPC785PVDF1
·
Model: MPC-785-PVDF
·
MOLDED PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Molded Products, Inc.
- Primary DI
- B144MPC785PVDF1
- Version / Model
- MPC-785-PVDF
- Catalog Number
- MPC-785-PVDF
- Company Name
- MOLDED PRODUCTS, INC.
- Labeler DUNS
- 157506015
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-10-04
- Public Version
- 1
- Public Version Date
- 2022-10-12
- Public Version Status
- New
- Public Device Record Key
- b9e33563-b1cf-4c6f-a96a-745bcc37127d
Device Description
Male Hansen Connector 1/4-18 NPTF/Kynar
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 |
|---|---|---|---|---|
| 58130 | Haemodialysis system, institutional | An assembly of mains electricity (AC-powered) devices intended to be used to perform patient haemodialysis, a treatment whereby extracorporeal blood is passed through a filter to allow for the removal of toxins and/or the replacement of electrolytes, by trained professionals in a healthcare facility. The system functions with dialysate solution and a haemodialysis dialyser (haemodialyzer) for the transfer of substances by diffusion, osmosis and ultrafiltration. It typically includes a pump and tubing to circulate blood through the haemodialysis dialyser, a solution mixer to prepare the dialysate, a monitor with system controls, and other dedicated components. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B144MPC785PVDF1 | HIBCC | ||||
| Unit of Use | B144MPC785PVDF0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K022068 | 000 |