Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014499739

FEI Number

3014499739

Entity Name

Medline International B.V.

City/State/Country

Gelang Patah Johor, MY

Establishment Address

(147186-D), D37C, Jalan DPB3, Pelabuhan Tanjung Pelepas, Gelang Patah Johor 81560, MY

Establishment Type(s)

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

Owner / Operator

Medline Industries, LP (Owner Number: 1417592)

Owner / Operator Contact Address

Three Lakes Drive, Northfield, IL 60093, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K930525

PMA Number

N/A

All Registered Proprietary Names

AVENUE Insertion Tool NAMIC MLL-RA Adaptor NAMIC Manifold Clamp NAMIC Standard Peripheral Vascular Angiographic Kit NAMIC Angiographic Pressure Monitoring Manifolds NAMIC Angiographic Manifold NAMIC Standard Angiographic Kit NAMIC Stopcock Medline Ventilator Tubing Medline Hudson RCI CORR-A-FLEX Corrugated Tubing NAMIC Stopcock NAMIC Port Protector Medline Hudson RCI Face Tent Medline Tracheostomy Mask Medline Oxygen Mask Medline Hudson RCI High-Concentration Oxygen Masks Hudson RCI High Concentration Oxygen Mask NAMIC Contrast Injection Line Medline Hudson RCI Tee Adapter Medline Pressure Tubing and Accessories Medline Pressure Monitoring Tubing Medline Aerosol Tubing Dynacor Oxygen Connecting Tube Hudson RCI Oxygen Supply Tubing Connector Medline Christmas Tree Style Nut and Nipple Adapter NAMIC Tri-Adaptor NAMIC Y-Adaptor NAMIC Tri-Adaptor Kit NAMIC Y-Adaptor Kit Medline Hudson Micro Mist Nebulizer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-11-04
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2019-10-22
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2016-07-20
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2009-01-16
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2019-10-22
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2022-06-23
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2009-01-16
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2022-06-23
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2019-10-24
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2024-01-05
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2006-04-11
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2019-11-12
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2022-07-25

Official Correspondent

Stephanie Augsburg

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

Medline Industries, LP

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007128716	Medline Industries, LP	Norristown, PA, US
3036706541	EXCELSIOR MEDICAL LLC	Tinton Falls, NJ, US
3016073670	Medline Logistics Japan G.K.	Nishihocho, Aisai-shi Aichi, JP
3006581049	MICROTEK MEDICAL MALTA LIMITED	Mosta, MT
3010389834	Microtek Medical B.V. Varsseveld	VARSSEVELD Gelderland, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31
K992169	Advanced Cardiovascular Systems, Inc.	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	1999-10-28
K012534	Advanced Cardiovascular Systems, Inc.	HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	2002-01-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562

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3015522130	NANO4IMAGING USA, LLC.	Dublin, OH, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014499739. Last updated year: 2026. Please use registration number 3014499739 when referencing this establishment in official correspondence.