Data / Medical devices / New Zealand / Shipserve New Zealand Limited
Shipserve New Zealand Limited: FDA-registered device maker in Ellerslie Auckland, New Zealand, 31 510(k) clearances
Shipserve New Zealand Limited is registered with the FDA (registration 3012809732) in Ellerslie Auckland, New Zealand. It lists 17 device types. The FDA files 31 510(k) clearances under its listings, the newest dated December 28, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012809732
- Address
- 22a Kalmia Street Unit 9, Ellerslie Auckland, New Zealand, 1542 NZ
- Owner or operator
- ShipServe New Zealand Limited (10051923)
- Roles
- Exporter to the US
- First device listed
- May 19, 2016
- Registered through
- 2026
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 28, 2015 | K153158 | Solution Administration Sets with 0.2 Micron Filter | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| August 18, 2014 | K142011 | SOLUTION SET/EXTENSION SET | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| October 8, 2013 | K132734 | NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| March 1, 2013 | K130245 | LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO | FMG | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| January 8, 2013 | K123868 | INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| October 18, 2011 | K112893 | CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| July 19, 2011 | K110443 | BD INSYTE AUTOGUARD BC | FOZ | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| May 13, 2011 | K110771 | BD SINGLE USE, HYPODERMIC SYRINGE | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| January 6, 2011 | K102520 | BD NEXIVA CLOSED IV CATHETER SYSTEM | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| October 9, 2009 | K091758 | BD SPINAL NEEDLE 27G | BSP | Substantially Equivalent | Becton Dickson & Co. | accessdata.fda.gov |
| September 29, 2004 | K040658 | BARDEX I.C. LATEX FOLEY CATHETER | MJC | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| July 19, 2002 | K021475 | BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET | FMI | Substantially Equivalent | Bd | accessdata.fda.gov |
| December 21, 2001 | K013800 | INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| March 1, 2001 | K010188 | BD ECLIPSE HYPODERMIC NEEDLE | FMI | Substantially Equivalent | Bd Medical Systems | accessdata.fda.gov |
| October 1, 1999 | K992734 | BECTON DICKINSON SYRINGE | MEG | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| August 20, 1999 | K990236 | MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT | FOZ | Substantially Equivalent | Johnson & Johnson Medical, Div. of Ethicon, Inc. | accessdata.fda.gov |
| June 14, 1999 | K991758 | MONOJECT INSULIN SYRINGE | FMF | Substantially Equivalent | The Kendal Co. | accessdata.fda.gov |
| October 28, 1998 | K982541 | VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 | FMI | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| August 17, 1998 | K981792 | SOLUTION ADMINISTRATION SET | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| June 3, 1998 | K974363 | BECTON DICKINSON BLUNT PLASTIC CANNULA | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| May 29, 1997 | K970803 | ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE | MEG | Substantially Equivalent | Retractable Technologies, Inc. | accessdata.fda.gov |
| March 31, 1997 | K964853 | INTRAVIA CONTAINER, EMPTY | KPE | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| June 21, 1996 | K961225 | CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| May 14, 1996 | K960787 | TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS | LJH | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| October 7, 1995 | K951254 | SAFETYGLIDE NEEDLE | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| July 31, 1995 | K952861 | ANGIOCATH & INSYTE AUTOGUARD CATHETERS | FOZ | Substantially Equivalent | Becton Dickinson Vascular Access, Inc. | accessdata.fda.gov |
| December 6, 1994 | K931052 | METRICIDE 28 | MED | Substantially Equivalent | Metrex Research Corp. | accessdata.fda.gov |
| February 22, 1994 | K932512 | MULTI-PORT MANIFOLD | FMG | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| June 18, 1993 | K925126 | INTERLINK(TM) INJECTION SITE | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| April 20, 1993 | K921899 | INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| March 12, 1992 | K915390 | 3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
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Updated December 28, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.