FDA UDI
In Commercial Distribution
🇺🇸 United States
Merit Medical®
DI: 00884450809310
·
Model: Initial Release
·
Merit Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Merit Medical®
- Primary DI
- 00884450809310
- Version / Model
- Initial Release
- Catalog Number
- 48MMTA
- Company Name
- Merit Medical Systems, Inc.
- Labeler DUNS
- 184763290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-28
- Public Version
- 1
- Public Version Date
- 2025-01-06
- Public Version Status
- New
- Public Device Record Key
- 3a2ca8cb-32bf-4349-96b1-7d4ba775d053
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PYC | Paracentesis tray | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64512 | Closed-wound drain connection tubing set | A device collection which includes flexible, noninvasive tubing (typically single or Y-shaped) and associated items (typically connectors, clamps, one-way valve and/or filter) intended to provide a connection between a surgical drain(s)/catheter(s) and a wound drainage container and/or suction source (the catheter, container and suction source are not included) to drain a closed wound. It is not intended to connect components of a surgical suction system (i.e., not used during general surgery). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10884450809317 | GS1 | 15 | In Commercial Distribution | ||
| Primary | 00884450809310 | GS1 | ||||
| Package | 20884450809314 | GS1 | 4 | In Commercial Distribution |