FDA UDI
In Commercial Distribution
🇺🇸 United States
IV Plus®
DI: 10892855000406
·
Model: N0657
·
NEXUS MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- IV Plus®
- Primary DI
- 10892855000406
- Version / Model
- N0657
- Company Name
- NEXUS MEDICAL, LLC
- Labeler DUNS
- 169260325
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- b60ea494-4106-4439-ad56-885850bac059
Device Description
Blunt Cannula in Blister Packs
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 |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44036 | Intravascular catheter adaptor | A connecting device, usually a small part, intended to be used to join an applied catheter to an external device(s) used in the intravenous administration of fluids to a patient. This device will typically be used when the devices to be connected are from different manufacturers and are non-compatible, enabling them to mate together. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30892855000400 | GS1 | 100 | In Commercial Distribution | ||
| Primary | 10892855000406 | GS1 |
Customer Contacts
- Phone
- 1866-336-3987
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081123 | 000 |