FDA UDI
In Commercial Distribution
🇺🇸 United States
Merit Medical®
DI: 00884450334652
·
Model: 00884450334652
·
Merit Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Merit Medical®
- Primary DI
- 00884450334652
- Version / Model
- 00884450334652
- Catalog Number
- HPT200E/A
- Company Name
- Merit Medical Systems, Inc.
- Labeler DUNS
- 184763290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-07
- Public Version
- 2
- Public Version Date
- 2021-11-01
- Public Version Status
- Update
- Public Device Record Key
- 959b4365-cd26-4462-9aa1-ce61a26e09c3
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 |
|---|---|---|---|---|
| DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | Cardiovascular | 870.2450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44685 | Radiographic procedure tubing | A flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884450334656 | GS1 | 4 | In Commercial Distribution | ||
| Package | 10884450334659 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 00884450334652 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Tubing Length (in/cm)-20" (51 cm) | ||
| Device Size Text, specify | Pressure Rating psi (bar)-1200 psi (83 bar) |