FDA UDI
In Commercial Distribution
🇺🇸 United States
WoundPro Basic Series Y-Connector
DI: 10851978007419
·
Model: 8463540 0674
·
Pensar Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- WoundPro Basic Series Y-Connector
- Primary DI
- 10851978007419
- Version / Model
- 8463540 0674
- Company Name
- Pensar Medical, LLC
- Labeler DUNS
- 079262228
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-10-10
- Public Version
- 1
- Public Version Date
- 2022-10-18
- Public Version Status
- New
- Public Device Record Key
- e4542c7f-d3db-4ec2-8f65-67d0bd029208
Device Description
WoundPro Basic Series Y-Connector, 10 per case
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | 878.4780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63418 | Low-pressure tubing connector, single-use, non-sterile | A non-sterile device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00851978007412 | GS1 | ||||
| Primary | 10851978007419 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150960 | 000 |