Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012809732

FEI Number

3012809732

Entity Name

SHIPSERVE NEW ZEALAND LIMITED

City/State/Country

Ellerslie Auckland, NZ

Establishment Address

22a Kalmia Street, Unit 9, Ellerslie Auckland 1542 NZ, NZ

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ShipServe New Zealand Limited (Owner Number: 10051923)

Owner / Operator Contact Address

22a Kalmia Street, Unit 9, Ellerslie, NZ-AUK 1542 NZ, NZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K992734

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-05-19
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2018-09-07
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2017-12-20
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2016-10-14
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-06-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-02-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-05-19
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-07-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-05-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-05-19
MED	Sterilant, Medical Devices	General Hospital	Class 2	880.6885	2016-08-08
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-09-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-05-19
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2016-08-08
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2016-10-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-03
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-04-16
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-07-28
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2020-07-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-07-06
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-07-06
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-06-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-10-14
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2017-03-29
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-05-19
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2020-07-01

Official Correspondent

John Blunsdon

US Agent Details

Michael Neuhaus Business: Carnival Distribution Email: carnivaldistusa@gmail.com Phone: (973) 3053664

Related Public Records

Same Entity

ShipServe New Zealand Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

Similar Registrations

Registration Number	Establishment Name	Location
3018229072	INNOVATIVE HEALTH SCIENCES	Chester, NY, US
3030989877	INTERNATIONAL FILTER PRODUCTS DBA IFP MEDICAL	Sun Valley, CA, US
1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US
3002807090	Sterigenics Germany GmbH	Wiesbaden Hesse, DE
3013319212	ICU MEDICAL, INC.	Lake Forest, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012809732. Last updated year: 2026. Please use registration number 3012809732 when referencing this establishment in official correspondence.