Data / Medical devices / Malaysia / Medline International B.V.
Medline International B.V.: FDA-registered device maker in Gelang Patah Johor, Malaysia, 9 510(k) clearances
Medline International B.V. is registered with the FDA (registration 3014499739) in Gelang Patah Johor, Malaysia. It lists 11 device types. The FDA files 9 510(k) clearances under its listings, the newest dated October 26, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014499739
- Address
- (147186-D), D37C, Jalan DPB3 Pelabuhan Tanjung Pelepas, Gelang Patah Johor, Malaysia, 81560
- Owner or operator
- Medline Industries, LP (1417592)
- Roles
- Exporter to the US
- First device listed
- April 11, 2006
- Registered through
- 2026
- Brand names listed
- AVENUE Insertion Tool, Dynacor Oxygen Connecting Tube, Hudson RCI High Concentration Oxygen Mask, Hudson RCI Oxygen Supply Tubing Connector, Medline Aerosol Tubing, Medline Christmas Tree Style Nut and Nipple Adapter, Medline Hudson Micro Mist Nebulizer, Medline Hudson RCI CORR-A-FLEX Corrugated Tubing and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | 2 | Exporter to the US | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Exporter to the US | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Exporter to the US | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Exporter to the US | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Exporter to the US | accessdata.fda.gov |
| Monitor, Line Isolation | DRI | 1 | Exporter to the US | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Exporter to the US | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Exporter to the US | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Exporter to the US | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | Exporter to the US | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Exporter to the US | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| October 26, 2023 | K230559 | Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) | BTT | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| September 29, 1993 | K930525 | MICRO MIST(TM) NEBULIZER | CAF | Substantially Equivalent | Hudson Respiratory Care, Inc. | accessdata.fda.gov |
| July 23, 1992 | K922410 | SCIMED AVENUE CORONARY GUIDEWIRE INSERTION TOOL | DQX | Substantially Equivalent | Scimed Life Systems, Inc. | accessdata.fda.gov |
| July 18, 1990 | K900783 | MDI ADAPTOR | CAF | Substantially Equivalent | Hudson Oxygen Therapy Sales Co. | accessdata.fda.gov |
| June 26, 1990 | K900652 | NAMIC PTCA Y-ADAPTOR | DTL | Substantially Equivalent | North American Instrument Corp. | accessdata.fda.gov |
| April 21, 1987 | K871157 | C.P.A.P. NASAL CANNULA | BZD | Substantially Equivalent | Hudson Oxygen Therapy Sales Co. | accessdata.fda.gov |
| October 18, 1984 | K842829 | HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS | DTL | Substantially Equivalent | North American Instrument Corp. | accessdata.fda.gov |
| August 24, 1982 | K822100 | HIGH PRESSURE CONTRAST INJECTION LINE | DQO | Substantially Equivalent | Namic | accessdata.fda.gov |
| January 23, 1979 | K782095 | STOPCOCKS, MANIFOLDS | DTL | Substantially Equivalent | Namic | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Mask, Oxygen, Non-Rebreathing
- All makers of Mask, Oxygen
- All makers of Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- All makers of Set, Tubing And Support, Ventilator (W Harness)
Updated October 26, 2023. 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.