Data / Medical devices / China / Sunmed Ap, Ltd., Warehouse No. 2
Sunmed Ap, Ltd., Warehouse No. 2: FDA-registered device maker in ZHUHAI Guangdong, China, 10 510(k) clearances
Sunmed Ap, Ltd., Warehouse No. 2 is registered with the FDA (registration 3044994756) in ZHUHAI Guangdong, China. It lists 16 device types. The FDA files 10 510(k) clearances under its listings, the newest dated November 16, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3044994756
- Address
- 1ST Floor Warehouse No. 2 SF Express Supply Chain Comprehensive Logistics Park No. 320 Ganli RD. Doumen District, ZHUHAI Guangdong, China, CN 519100
- Owner or operator
- VENTLAB, LLC (2246980)
- Roles
- Exporter to the US
- First device listed
- November 19, 1992
- Registered through
- 2027
- Brand names listed
- Aerial, Alliance Tech Medical, BreathTech, BreathTech Hyperinflation System, BreathTech Mask, Breathing Circuits, Breathrite Spacer, CombiGuard and more
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 |
|---|---|---|---|---|---|---|
| November 16, 2018 | K173373 | SafeT T-Piece Resuscitator | BTL | Substantially Equivalent | Ventlab, LLC | accessdata.fda.gov |
| September 21, 2017 | K161719 | Salter Labs Bubble Humidifier | BTT | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| June 9, 2008 | K080366 | DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES | DXQ | Substantially Equivalent | Zefon Intl. | accessdata.fda.gov |
| July 7, 2003 | K030271 | VENTLAB BACTERIAL FILTER, MODEL BF100 | CAH | Substantially Equivalent | Ventlab Corp. | accessdata.fda.gov |
| February 11, 2002 | K020281 | MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM | NHK | Substantially Equivalent | Ventlab Corp. | accessdata.fda.gov |
| August 24, 1998 | K981944 | BREATHERITE | CAF | Substantially Equivalent | Ventlab Corp. | accessdata.fda.gov |
| August 13, 1996 | K961867 | PEEP VALVE | BYE | Substantially Equivalent | Medical Marketing Concepts | accessdata.fda.gov |
| August 15, 1995 | K953107 | ANESTHESIA/RESPIRATORY FACE MASK | BSJ | Substantially Equivalent | Medical Marketing Concepts | accessdata.fda.gov |
| July 23, 1993 | K932709 | PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM | BZR | Substantially Equivalent | Precision Med Products, Ltd. | accessdata.fda.gov |
| July 23, 1992 | K921997 | CUFF-M | DXQ | Substantially Equivalent | Lorin Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Oxygen
- All makers of Circuit, Breathing (W Connector, Adaptor, Y Piece)
- All makers of Resuscitator, Manual, Non Self-Inflating
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Blood Pressure Cuff
- All makers of Mask, Gas, Anesthetic
Updated November 16, 2018. 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.