FDA UDI
In Commercial Distribution
🇺🇸 United States
Molded Products, Inc.
DI: B144MPC80050
·
Model: MPC-800-5
·
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
- B144MPC80050
- Version / Model
- MPC-800-5
- Catalog Number
- MPC-800-5
- 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
- 2
- Public Version Date
- 2019-09-12
- Public Version Status
- Update
- Public Device Record Key
- e226cc3b-f109-4399-a756-afdf5f545da9
Device Description
Sterile Double DIN to DIN "Y" Connector
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KOC | Accessories, Blood Circuit, Hemodialysis | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34999 | Haemodialysis blood tubing set, single-use | A collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B144MPC80053 | HIBCC | Case | 30 | In Commercial Distribution | |
| Package | B144MPC80051 | HIBCC | Bag | 25 | In Commercial Distribution | |
| Primary | B144MPC80050 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K003712 | 000 |