Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005998497

FEI Number

3005998497

Entity Name

SUNMED AP, LTD.

City/State/Country

ZHUHAI Guangdong, CN

Establishment Address

6-9 ZHUFENG RD., QIANNAN INDUSTRIAL PARK, QIANWU TOWN, DOUMEN DISTRICT, ZHUHAI Guangdong 519170, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

VENTLAB, LLC (Owner Number: 2246980)

Owner / Operator Contact Address

2710 Northridge Dr. NW, Suite A, --, Grand Rapids, MI 49544, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BreathTech Aerial Alliance Tech Medical Breathrite Spacer Infu-Surg Bag Pressure Infusion Bag Infusor, Disposable, INFUSEIT Oxygen Tubing Ventlab Pressure Tubing and Accessories Medline Ventlab BreathTech Medline BreathTech Ventlab Medline Disposable BV Filter MedLine HME Filter BreathTech PEEP Valve BreathTech Hyperinflation System Ventlab Hyperinflation System End Tidal CO2 Cannula MedLine Cannula DuraCheck Blood Pressure Cuffs BreathTech Mask Vent Mask Soft-Aire Mask Vent Mask II Soft Seal Mask SunMed SafeT T Piece Resuscitator StatCheck II CO2 Indicator Salter Labs Bubble Humidifier Salter Labs Humidifer Breathing Circuits Colormetric etCO2 detector (MaxCap) Provider Enterprise CombiGuard Bite Block Block Soft Seal Mask GE Healthcare Vent Mask BreathTech Soft-Aire Medline Vent Mask II Ventlab Oxygen Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-17
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2001-09-26
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	1992-11-19
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2006-08-03
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2006-08-03
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2007-12-17
NHK	Resuscitator, Manual, Non Self-Inflating	Anesthesiology	Class 2	868.5905	2007-12-17
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-07-27
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2024-09-06
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	1992-11-19
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2019-01-07
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2010-12-20
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2021-09-08
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2006-08-03
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2024-08-27
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2007-12-17
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2016-09-14
JXL	Block, Bite	Neurology	Class 2	882.5070	2023-02-17
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2010-12-20
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2001-07-24

Official Correspondent

Rob Yamashita

US Agent Details

Rob Yamashita Business: AirLife Email: ryamashita@myairlife.com Phone: (616) 2598373

Related Public Records

Same Entity

VENTLAB, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3044994756	SUNMED AP, LTD., WAREHOUSE NO. 2	ZHUHAI Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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3018783526	CEVA LOGISTICS NETHERLANDS BV (Venray)	Oostrum Limburgh, NL
3006852037	Omron Healthcare Manufacturing Vietnam Co., Ltd.	Ho Chi Minh City, VN
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005998497. Last updated year: 2026. Please use registration number 3005998497 when referencing this establishment in official correspondence.