FDA UDI
In Commercial Distribution
🇺🇸 United States
IV Plus
DI: 10815879021547
·
Model: N0669
·
NEXUS MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- IV Plus
- Primary DI
- 10815879021547
- Version / Model
- N0669
- Company Name
- NEXUS MEDICAL, LLC
- Labeler DUNS
- 169260325
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-08
- Public Version
- 1
- Public Version Date
- 2022-09-16
- Public Version Status
- New
- Public Device Record Key
- b06d746b-b94a-4350-bd1e-9489000c51e2
Device Description
Mini Vented Transfer Pin with Nexus NIS®-6P
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
- 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 |
|---|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43324 | Fluid transfer set, general-purpose | A collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30815879021541 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 10815879021547 | GS1 |
Customer Contacts
- Phone
- 866-336-3987
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080976 | 000 |