Besmed Bacterial Filter and HMEF
Besmed Health Business Corp
Besmed Health Business Corporation
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9710567 | 3003256355 | Besmed Health Business Corporation | 1 | N | 2026-01-01 | No. 5, Lane 116, Wu-Kong 2nd Rd. Wu-ku District New Taipei City TW 24888 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 81299 | 1110433174 | K241339 | Besmed Bacterial Filter and HMEF | CAH | 2024-11-14 |
| 81299 | 1447867981 | K172804 | Besmed Peak Flow Meter | BZH | 2018-01-11 |
| 81299 | 1813403550 | K160112 | Besmed PEEP Valve | BYE | 2016-04-29 |
| 81299 | 1724297900 | K150591 | Besmed Reusable Jet Nebulizer | CAF | 2015-06-30 |
| 81299 | 1007470132 | K143150 | CO2 monitoring line with and without in-line filter | CCK | 2015-02-05 |
| 81299 | 2030571721 | K141355 | VOLUMETRIC INCENTIVE SPIROMETER | BWF | 2014-09-03 |
| 81299 | 1045069457 | K140370 | DISPOSABLE PRESSURE MANOMETER | CAP | 2014-06-19 |
| 81299 | 1493201183 | K133873 | TRIBALL INCENTIVE SPIROMETER | BWF | 2014-04-04 |
| 81299 | 2052584142 | K091272 | BESMED JET NEBULIZER BOTTLE SET | CAF | 2009-11-10 |
| 81299 | 1155072428 | K031375 | BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580 | IPF | 2003-11-20 |
| 81299 | 1744896846 | K031374 | BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 | GZJ | 2003-11-28 |
| 81299 | 1866646196 | K021446 | OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR | BTM | 2002-10-11 |
| 81299 | 1729692071 | K021442 | OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR | BTM | 2002-07-30 |
| 81299 | 1023547868 | ||||
| 81299 | 1156607582 | ||||
| 81299 | 1157247072 | ||||
| 81299 | 1164274365 | ||||
| 81299 | 1167159852 | ||||
| 81299 | 1223229030 | ||||
| 81299 | 1250076394 | ||||
| 81299 | 1264901079 | ||||
| 81299 | 1309090657 | ||||
| 81299 | 1313408833 | ||||
| 81299 | 1336812176 | ||||
| 81299 | 1344012775 | ||||
| 81299 | 1374957867 | ||||
| 81299 | 1383239061 | ||||
| 81299 | 1385998590 | ||||
| 81299 | 1408290534 | ||||
| 81299 | 1444185134 | ||||
| 81299 | 1486361042 | ||||
| 81299 | 1500937338 | ||||
| 81299 | 1522863333 | ||||
| 81299 | 1542637469 | ||||
| 81299 | 1563930881 | ||||
| 81299 | 1625669854 | ||||
| 81299 | 1671319559 | ||||
| 81299 | 1715682180 | ||||
| 81299 | 1820800321 | ||||
| 81299 | 1832446489 | ||||
| 81299 | 1859795277 | ||||
| 81299 | 1894646705 | ||||
| 81299 | 1925332534 | ||||
| 81299 | 1944658770 | ||||
| 81299 | 1962544676 | ||||
| 81299 | 1973943660 | ||||
| 81299 | 1985031052 | ||||
| 81299 | 1998591726 | ||||
| 81299 | 1999194182 | ||||
| 81299 | 2029930695 |
Product Codes Associated With Registrations#
PMN#
Besmed Peak Flow Meter
Besmed Health Business Corp.
Besmed PEEP Valve
BESMED HEALTH BUSINESS CORP.
Besmed Reusable Jet Nebulizer
BESMED HEALTH BUSINESS CORP.
CO2 Monitoring Line With And Without In-line Filter
BESMED HEALTH BUSINESS CORP.
VOLUMETRIC INCENTIVE SPIROMETER
BESMED HEALTH BUSINESS CORPORATION
DISPOSABLE PRESSURE MANOMETER
BESMED HEALTH BUSINESS CORP.
TRIBALL INCENTIVE SPIROMETER
BESMED HEALTH BUSINESS CORP.
BESMED JET NEBULIZER BOTTLE SET
BESMED HEALTH BUSINESS CORP.
BESMED VARIOUS MODELS OF TENS, BE-550/BE-660
BESMED HEALTH BUSINESS CORP.
BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580
BESMED HEALTH BUSINESS CORP.
GUDID#
HMEF (Dead space 60ml) - FL-70306
2026-02-11
HMEF W/Luer lock port (Dead space 60ml) - FL-70303
2026-02-11
HMEF W/Luer lock port (Dead space 45ml) - FL-70302
2026-02-11
Bacterial Filter (Dead space 32ml) - FL-70223
2026-02-11
Angled HME with luer lock port - FL-70115
2026-02-11
HME W/Luer lock port (Dead space 45ml) - FL-70112
2026-02-11
HMEF (Dead space 60ml) - FL-70306
2026-02-11
HMEF W/Luer lock port (Dead space 60ml) - FL-70303
2026-02-11
HMEF W/Luer lock port (Dead space 45ml) - FL-70302
2026-02-11
Besmed Menstrual Cup - Purple Menstrual Cup Second Generation
2022-12-09
Besmed Menstrual Cup - Large White Menstrual Cup
2022-12-09
Besmed Menstrual Cup - Medium White Menstrual Cup
2022-12-08
Besmed Menstrual Cup - Small White Menstrual Cup
2022-12-08
INCENTIVE SPIROMETER - TB-93501
2017-12-15
INCENTIVE SPIROMETER,5000ML - TB-93500
2016-09-06
INCENTIVE SPIROMETER - TB-93251
2017-12-15
INCENTIVE SPIROMETER,2500ML - TB-93250
2016-09-06
INCENTIVE SPIROMETER,600/900/1200ML - TB-93100
2016-09-06
Nebulizer,pacifier - MP-79120
2017-12-13
MOUTH PIECE (ID:18mm, OD:19.5mm) - MP-79109
2017-12-13
MOUTH PIECE(OD:22mm) - MP-79108
2017-12-13
MOUTH PIECE (OD:18mm,22mm) - MP-79104
2017-12-13
Elbow connetor 18MM ID for nebulizer - MP-79001
2017-12-13
DIGITAL TENS DUAL CHANNEL - BE-92580
2017-12-15
DIGITAL TENS ONE CHANNEL - BE-92560
2017-12-15
Digital tens one channel - BE-560
2016-09-07
Straight Connector 15F/22M, 15M W/PORT & CAP - CT-14330
2021-01-07
ICU gas sampling pack with flowmeter - OEM ref: C05096-02-11
2022-08-08
ICU gas sampling pack - OEM ref: C05096-01-11
2022-08-08
Oxygen Nasal Cannula Infant,W/co2 Sampling line(Male Luer),Universal O2 Connect - NC-87510
2016-09-12
Oxygen Nasal Cannula Infant,W/co2 Sampling line(Female LUER) - NC-87505
2016-09-12
Oxygen Nasal Cannula Infant,W/co2 Sampling line(Male Luer) - NC-87500
2016-09-07
Oxygen Nasal Cannula Child,W/co2 Sampling line(Male Luer),Universal O2 Connecto - NC-87410
2016-09-12
Oxygen Nasal Cannula Child,W/co2 Sampling line(Female LUER) - NC-87405
2016-09-08
Oxygen Nasal Cannula Child,W/co2 Sampling line(Male Luer) - NC-87400
2016-09-07
Oxygen Nasal Cannula Adult,W/co2 Sampling line(Male Luer),Universal O2 Connector - NC-87310
2016-09-12
Oxygen Nasal Cannula Adult,W/co2 Sampling line(Female LUER) - NC-87305
2016-09-08
Oxygen Nasal Cannula Adult,W/co2 Sampling line(Male Luer) - NC-87300
2016-09-07
GAS SAMPLING LINE-2.0M (MALE/FEMALE) - OT-83620
2016-09-07
OXYGEN TUBING, DISOSABLE, W/14FT TUBE (UNIVERSAL CONNECTOR ON ONE SIDE) - OT-83542
2017-12-28