FDA UDI
In Commercial Distribution
🇺🇸 United States
XLR8/XLR8+ Port
DI: 00849405001454
·
Model: XP-1013
·
GENADYNE BIOTECHNOLOGIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- XLR8/XLR8+ Port
- Primary DI
- 00849405001454
- Version / Model
- XP-1013
- Catalog Number
- XP-1013
- Company Name
- GENADYNE BIOTECHNOLOGIES INC.
- Labeler DUNS
- 006616130
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-19
- Public Version
- 1
- Public Version Date
- 2023-12-27
- Public Version Status
- New
- Public Device Record Key
- 3060e5bf-2552-46eb-a139-03d27874ffed
Device Description
Medical grade suction port that has a PU film with acrylic adhesive attached to it.
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
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 61146 | Irrigation negative-pressure wound therapy unit | A mains electricity (AC-powered) device designed to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic) using suction combined with instillation/aspiration of wound treatment solutions (e.g., saline) over the wound bed. It typically includes controls and a user-interface to vary negative pressure and irrigation parameters, tubing, and a collection receptacle. It is intended to reduce oedema, promote granulation tissue formation, and remove exudates and infectious material. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00849405001454 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143726 | 000 |