IV Plus® N0606
IV Plus N0606 is an intravenous fluid bag spike (FDA Class II; FDA product code LHI, Set, I.V. Fluid Transfer) made by Nexus Medical, LLC, cleared under FDA 510(k) K080976 on 10 Nov 2008 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 10892855000819), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10892855000819 | Date12 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK080976 | Date10 Nov 2008 | StatusActive |
Official records
- AccessGUDID record 10892855000819
- FDA 510(k) database K080976
Across registries
- FDA 510(k) K080976 decided 10 Nov 2008 Active
- FDA GUDID UDI-DI 10892855000819 listed 12 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K080976
- Listed FDA GUDID 10892855000819
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- IV Plus®
- Generic name
- Intravenous fluid bag spike
- Model / reference
- N0606
- Primary DI / UDI-DI
- 10892855000819
- 510(k) Number
- FDA product code
- LHI
- GMDN term
- Intravenous fluid bag spike
- Device class
- Class II
- Regulation number
- 880.5440
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code LHI (Set, I.V. Fluid Transfer).
- TANDEM SETS I.V. by Acacia, Inc.
- STATLOCK by Healthtek, Inc.
- SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE by LABORATORIOS GRIFOLS, S.A.
- Vial Adapter by Shanghai Lingfu Technology Co., Ltd.
- Vial Adaptor 8070311 by West Pharma. Services IL, Ltd.
- Vial Adapter 8070114 by West Pharma. Services IL, Ltd.
- VENTED I.V. TRANSFER NEEDLE by Baxa Corp., Sub. of Cook Group, Inc.
- MEDSOURCE IV ADMINSTRATION SET by MEDSOURCE INTERNATIONAL LLC
- INFUSION ADAPTER C100 by Carmel Pharma Ab.
- TRANSFER SET by Puritas Health Care, Inc.