FDA UDI
In Commercial Distribution
🇺🇸 United States
Molded Products, Inc.
DI: B144MPC1100
·
Model: MPC-110
·
MOLDED PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Molded Products, Inc.
- Primary DI
- B144MPC1100
- Version / Model
- MPC-110
- Catalog Number
- MPC-110
- Company Name
- MOLDED PRODUCTS, INC.
- Labeler DUNS
- 157506015
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-04
- Public Version
- 4
- Public Version Date
- 2025-08-18
- Public Version Status
- Update
- Public Device Record Key
- e9a1fabc-6af8-4495-96f1-26d2c308a766
Device Description
NeedleFree Injection Site
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
- Yes
- 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 |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16858 | Catheter injection port | A device intended to be placed on the Luer end of a catheter or intravenous (IV) tubing as a site of injection of substances into the in situ catheter/tubing. Some types may be designed as a Y-connector with an additional inlet (e.g., with a female Luer connection point) to facilitate sequential injection and infusion of fluids (e.g., medication followed by saline). It may be additionally intended for use as a heparin/saline lock by keeping the flush solution in the catheter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B144MPC1101 | HIBCC | 100 | In Commercial Distribution | ||
| Primary | B144MPC1100 | HIBCC | ||||
| Package | B144MPC1104 | HIBCC | 40 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K925927 | 000 |