FDA UDI
In Commercial Distribution
🇺🇸 United States
Molded Products, Inc.
DI: B144MPC250XL1
·
Model: MPC-250XL
·
MOLDED PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- Molded Products, Inc.
- Primary DI
- B144MPC250XL1
- Version / Model
- MPC-250XL
- Catalog Number
- MPC-250XL
- Company Name
- MOLDED PRODUCTS, INC.
- Labeler DUNS
- 157506015
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2023-06-05
- Public Version
- 1
- Public Version Date
- 2023-06-13
- Public Version Status
- New
- Public Device Record Key
- 6880799b-7b7b-46be-96f3-f722b931f2f6
Device Description
Extra Large Fistula Pressure Clamp
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
- Yes
- 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 |
|---|---|---|---|---|
| HXD | Clamp | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46604 | Vascular puncture haemostasis arm clamp/band, reusable | A semi-flexible, adjustable, clamp or band/strap device designed for application over an arterial/venous/fistula needle-puncture site in a patient’s arm to provide uniform pressure and achieve haemostasis. Commonly used on haemodialysis patients, some types are referred to as fistula clamps. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B144MPC250XL2 | HIBCC | Case | 50 | In Commercial Distribution | |
| Primary | B144MPC250XL1 | HIBCC | ||||
| Unit of Use | B144MPC250XL0 | HIBCC |