Gyun e zero sterilization tissue
ALCOHOL
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| SUNMED AP, LTD., WAREHOUSE NO. 2 | 5 | N | 2026-01-01 | 1ST FLOOR WAREHOUSE NO. 2 SF EXPRESS SUPPLY CHAIN COMPREHENSIVE LOGISTICS ZHUHAI Guangdong CN CN 519100 | ||
| 1314417 | 1314417 | SunMed Group Holdings, LLC | 1 | Y | 2026-01-01 | 2710 Northridge Dr NW Ste A Grand Rapids MI US 49544 |
| 1721819 | 1721819 | SUNMEDICA | 1 | N | 2026-01-01 | 5070 Mountain Lakes Blvd REDDING CA US 96003 |
| 3005998497 | 3005998497 | SUNMED AP, LTD. | 1 | N | 2026-01-01 | 6-9 ZHUFENG RD., QIANNAN INDUSTRIAL PARK QIANWU TOWN, DOUMEN DISTRICT ZHUHAI Guangdong CN 519170 |
| 3030308442 | 3030308442 | SUNMED GROUP HOLDINGS, LLC dba AirLife | 1 | Y | 2026-01-01 | 15152 W. Camelback Rd. Litchfield Park AZ US 85340 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 20889483033309 | SunMed - SunSlip Sheath Stylette - Infant | 1-800-433-2797 | info@sun-med.com |
| 20889483033316 | SunMed - SunSlip Sheath Stylette - Child | 1-800-433-2797 | info@sun-med.com |
| 20889483033323 | SunMed - SunSlip Sheath Stylette - Adult | 1-800-433-2797 | info@sun-med.com |
| 20889483230005 | VixOne™ - VixOne™ Nebulizer Mask Kit, Pediatric | 1-800-433-2797 | info@sun-med.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 161413 | 1692651350 | P890057 | MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR | LSZ | 1991-03-29 |
| 161413 | 1291299652 | K993833 | AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS | BZE | 1999-12-10 |
| 161413 | 2023554265 | K992986 | SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER | CAF | 1999-09-24 |
| 161413 | 1800196429 | K991484 | AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006 | BTT | 1999-05-13 |
| 36767 | 1366552825 | K990098 | VENTLAB VERIFY II | BTR | 1999-02-11 |
| 161413 | 1408252387 | K990098 | VENTLAB VERIFY II | BTR | 1999-02-11 |
| 36767 | 1349289676 | K982215 | MANUAL RESUSCITATOR WITH ACE | BTM | 1998-09-18 |
| 161413 | 1813872835 | K982215 | MANUAL RESUSCITATOR WITH ACE | BTM | 1998-09-18 |
| 36767 | 1430828373 | K981944 | BREATHERITE | CAF | 1998-08-24 |
| 161413 | 1913381199 | K981944 | BREATHERITE | CAF | 1998-08-24 |
| 161413 | 1879277267 | K971259 | COMBIPORT FLUID LAVAGE DEVICE | KDH | 1997-10-27 |
| 161413 | 1435312157 | K970811 | DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN | JOH | 1998-11-13 |
| 161413 | 1572271118 | K970359 | COMBIPROT EMERGENCY ENFUSION DEVICE | LHI | 1997-03-18 |
| 161413 | 2053583119 | K964204 | ENGSTROM HMEF 1000 | CAH | 1996-11-13 |
| 161413 | 1632421876 | K962879 | SALTERLABS 8660 SERIES NEBULIZER | CAF | 1996-10-22 |
| 161413 | 1278526195 | K962850 | TUM-E-VAC | KDH | 1997-02-21 |
| 161413 | 1611920571 | K962220 | HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER | BZE | 1997-01-14 |
| 161413 | 1122463165 | K962161 | BAXTER NEBULIZER CAP MODEL 2D0868 | CAF | 1996-08-15 |
| 161413 | 1736287296 | K962079 | HUMIDIFIER ADAPTER | BTT | 1996-07-31 |
| 36767 | 1657756892 | K961867 | PEEP VALVE | BYE | 1996-08-13 |
| 161413 | 2027944629 | K961867 | PEEP VALVE | BYE | 1996-08-13 |
| 161413 | 1372038613 | K961838 | RESPIRGARD II, SPIROGARD | CAH | 1996-10-18 |
| 161413 | 1732731136 | K961476 | SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984) | CAF | 1996-07-16 |
| 161413 | 1112610765 | K953546 | MANUAL PULMONARY RESUSICITATOR | BTM | 1996-02-29 |
| 36767 | 1857989945 | K953546 | MANUAL PULMONARY RESUSICITATOR | BTM | 1996-02-29 |
| 36767 | 1418995218 | K953107 | ANESTHESIA/RESPIRATORY FACE MASK | BSJ | 1995-08-15 |
| 161413 | 1568371977 | K951047 | BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA | CAH | 1995-06-02 |
| 161413 | 1379439129 | K943600 | UNIHEART | CAF | 1994-10-13 |
| 161413 | 1102032818 | K942211 | VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS | BTY | 1994-11-22 |
| 325042 | 1102032818 | K942211 | VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS | BTY | 1994-11-22 |
| 161413 | 1791061978 | K935633 | NO-MES | KNT | 1994-09-30 |
| 161413 | 1847310284 | K932799 | SINGLE USE MANUAL RESUSCITATOR PEEP VALVE | BYE | 1993-09-03 |
| 161413 | 1965810690 | K932710 | GAS SAMPLING LINES AND CONNECTORS | CAI | 1993-07-23 |
| 161413 | 1749157933 | K932709 | PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM | BZR | 1993-07-23 |
| 161413 | 1118353016 | K932557 | HYPERINFLATION SYSTEM | BZR | 1993-07-22 |
| 161413 | 1614153166 | K930957 | ZEFON GAS SAMPLING LINES | CCK | 1993-07-02 |
| 161413 | 1300279254 | K926055 | THE MILLER NEBULIZER SYSTEM | CAF | 1993-02-03 |
| 161413 | 1883697496 | K924671 | BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT | BTM | 1993-04-21 |
| 161413 | 1316972532 | K924610 | BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT | BTM | 1993-04-06 |
| 161413 | 1199055124 | K924123 | SIDESTREAM DISPOSABLE | CAF | 1992-11-16 |
| 161413 | 1910994068 | K923596 | HEART NEBULIZER | CAF | 1992-10-15 |
| 161413 | 1798666894 | K922492 | SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER | CAH | 1992-08-24 |
| 161413 | 2053855696 | K921946 | TUM-E-VAC BITE BLOCK | JXL | 1992-12-09 |
| 161413 | 1279944095 | K920885 | VENTILATOR CIRCUITS | CAH | 1992-10-23 |
| 161413 | 1461700255 | K920443 | MININEB | CAF | 1992-07-02 |
| 161413 | 1565474283 | K915277 | ENDOTRACHEAL CPAP SET | BTR | 1992-03-20 |
| 161413 | 2049513142 | K915226 | ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT | BZE | 1993-01-12 |
| 161413 | 1621129084 | K915073 | MARQUETTE SV O2 MODULE | DQE | 1992-12-29 |
| 161413 | 1208203438 | K914370 | MECONIUM SUCTION DEVICE (MSD) | BTR | 1993-01-06 |
| 161413 | 1292576635 | K914337 | GAS SAMPLING INTERFACES | CCK | 1992-03-11 |
| 161413 | 1439945142 | K912625 | MOUTH TO MASK RESUSCITATOR | BTM | 1991-08-02 |
| 161413 | 1359260339 | K912578 | 20CM/H20 PEEP VALVE | BYE | 1991-09-11 |
| 161413 | 1372615210 | K911865 | NORTEC CONNECTING TUBE SET | GAZ | 1991-11-01 |
| 161413 | 1389547054 | K911465 | INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL | BZD | 1991-10-18 |
| 161413 | 1748111480 | K910856 | MANUAL RESUSCITATOR | BTM | 1991-06-18 |
| 161413 | 1728034278 | K904874 | ADJUSTABLE PEEP VALVE | BYE | 1991-01-08 |
| 161413 | 1904560456 | K901728 | ONE-LUNG CPAP DEVICE | BYE | 1990-08-14 |
| 161413 | 1796230946 | K901301 | STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL | CAF | 1990-05-31 |
| 161413 | 1151175933 | K895913 | STANDARD NEBULIZER HEATER | CAF | 1989-12-22 |
| 161413 | 1838001569 | K885220 | PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT | KNT | 1989-09-25 |
| 161413 | 2068030507 | K883977 | SURGI-CUF STERILE/NON-STERILE DISPOSABLE | DXQ | 1989-02-10 |
| 161413 | 1929137253 | K883964 | AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER | CAF | 1988-11-30 |
| 161413 | 1852393573 | K881086 | LIFEGUARD MOUTH TO MASK RESUSCITATOR | BTM | 1988-04-14 |
| 161413 | 1184376792 | K874395 | RESPIRGARD II NEBULIZER SYSTEM | CAF | 1987-12-21 |
| 161413 | 1966240366 | K870332 | PREFILLED RESPIRATORY THERAPY VIALS | CCQ | 1987-04-01 |
| 161413 | 1759589862 | K870027 | HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER | CCQ | 1987-03-16 |
| 161413 | 1686587717 | K860599 | ETHOX LAVAGE TUBE | KDH | 1986-03-11 |
| 161413 | 1901267514 | K860510 | NEONATE PERCUSSOR | BYI | 1986-02-20 |
| 161413 | 1504714828 | K853146 | RESPIR THER HUMID CONTAIN STERILE WATER FOR USP | BTT | 1985-08-06 |
| 325042 | 1504714828 | K853146 | RESPIR THER HUMID CONTAIN STERILE WATER FOR USP | BTT | 1985-08-06 |
| 161413 | 1961389032 | K851074 | VARIABLE NEBULIZER HEATER | CAF | 1985-06-18 |
| 161413 | 1437164065 | K850265 | AMERICAN TWA WAY FILTER -BACTERIAL/VIRAL-RETENTIVE | CAH | 1985-04-05 |
| 161413 | 1072668250 | K844988 | ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS. | DXQ | 1985-04-04 |
| 161413 | 1801866466 | K840966 | ANESTHETIC GAS MONITOR SYS | CCK | 1984-05-14 |
| 161413 | 1609355434 | K831885 | CODE BLUE MANUAL RESUSCITATOR | BTM | 1983-09-08 |
| 161413 | 2045000144 | K831503 | DOWNS ADJUSTABLE FLOW GENERATOR | BYE | 1983-09-12 |
| 161413 | 1332311553 | K830943 | PREFILLED RESPIRATORY THERAPY VIAL | CAF | 1983-04-28 |
| 161413 | 1753875482 | K830895 | SINGLE USE NEBULIZER, ADJUST. AIR- | CAF | 1983-04-28 |
| 161413 | 1957131051 | K822811 | CONTAINERS OF STERILE WATER OS SALINE | BTO | 1982-10-27 |
| 161413 | 1249562305 | K820143 | XENON DELIVERY SYSTEM | IYT | 1982-03-02 |
| 161413 | 1062724790 | K812648 | EHTOX GASTRIC LAVAGE KIT #2050 & #2070 | KNT | 1981-09-29 |
| 161413 | 1423699018 | K812273 | RESUSCITATION CIRCUIT | BTM | 1981-08-25 |
| 161413 | 1644058223 | K811639 | ETHIX FEEDING TUBES POLYURETHANE/RADIOP. | KNT | 1981-06-26 |
| 161413 | 1510730183 | K802070 | VITAL SIGNS PEEP VALVE | BYE | 1980-09-09 |
| 161413 | 1231851989 | K801252 | NEBULIZER WITH AIR ENTERTAINER & ETC. | BTT | 1980-06-04 |
| 161413 | 1738870873 | K800753 | STERILE WATER & SALINE IN PLASTIC BTL. | BTT | 1980-04-24 |
| 161413 | 2073279613 | K800562 | DISPOSABLE HAND HELD NEBULIZER | CAF | 1980-03-25 |
| 161413 | 1816455925 | K792218 | MISTY BEBULIZER | CAF | 1979-11-27 |
| 161413 | 1677610907 | K791819 | AIR INCENTIVE SPIROMETER | BWF | 1979-09-26 |
| 161413 | 1799643243 | K791558 | TEMP-STIK MODEL #300 | FLL | 1979-09-12 |
| 161413 | 1696920235 | K791444 | UNIVERSAL TWO-PIECE MACHINES | CAF | 1979-08-28 |
| 161413 | 1774743499 | K791042 | I.P.P.B. MANIFOLD & NEBULIZER, UNIVERSAL | CAF | 1979-06-13 |
| 161413 | 1263423194 | K790892 | MISTY NEBULIZER | CAF | 1979-07-24 |
| 161413 | 1342259324 | K790888 | TRACH T WITH ONE-WAY VALVES | BZA | 1979-06-27 |
| 161413 | 1296780802 | K790151 | ONE-WAY VALVE | CBP | 1979-03-12 |
| 161413 | 1586338780 | K781600 | MISTY-OX PREFILLED HUMIDIFIER, DISP. | BTT | 1978-10-31 |
| 161413 | 1065763340 | K781428 | FLEXTUBES:9, 20, 26 | BYX | 1978-09-11 |
| 161413 | 1705468311 | K780456 | NEBULIZER HEATER | CAF | 1978-04-12 |
| 161413 | 2065594589 | K780385 | RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE | BTT | 1978-05-16 |
| 161413 | 2015963088 | K772222 | NEBULIZER SET-2C7105 | CAF | 1977-12-22 |
| 161413 | 1789544604 | K770590 | SURGI-KIT | KCT | 1977-04-14 |
| 161413 | 1424732822 | K760585 | U-MID PREFILLED NEBULIZER | CAF | 1976-10-15 |
| 161413 | 1063621522 | K760584 | U-MID PREFILLED HUMIDIFIER (500CC) | BTT | 1976-10-15 |
| 161413 | 1149766350 | K231380 | AirLife DuoTherm Humidification System | BTT | 2023-08-10 |
| 161413 | 1138915270 | K223551 | Sterile Water for Inhalation in 1L Flexoval ® bottles. | BTT | 2023-08-03 |
| 161413 | 1193677079 | K190853 | Vyntus BODY | BZC | 2019-08-16 |
| 161413 | 1189455102 | K182362 | MaxCap Ped and MaxCap Neo | CCK | 2019-05-23 |
| 161413 | 1859226339 | K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART | BZC | 2018-11-30 |
| 36767 | 1494474919 | K173373 | SafeT T-Piece Resuscitator | BTL | 2018-11-16 |
| 161413 | 1874094370 | K173373 | SafeT T-Piece Resuscitator | BTL | 2018-11-16 |
| 161413 | 1592957136 | K173147 | SuperNO2VA Et Device | CCK | 2018-06-20 |
| 161413 | 1021958259 | K170378 | AirLife Adult Heated Wire BiPAP/NIV Circuit | BZE | 2017-09-14 |
| 325042 | 1044613504 | K163316 | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System | DSA | 2017-06-22 |
| 161413 | 1422311890 | K163277 | SuperNO2VA Device | BSJ | 2017-10-13 |
| 161413 | 1189629060 | K162343 | Westmed Gas Sampling Cannula with O2 delivery | CCK | 2016-12-14 |
| 161413 | 1884409415 | K161719 | Salter Labs Bubble Humidifier | BTT | 2017-09-21 |
| 161413 | 1110013143 | K160764 | AirLife Autofill Humidification Chamber | BTT | 2016-08-25 |
| 161413 | 1832322817 | K153234 | AirLife Adult Heated Wire Circuit | BZE | 2016-07-07 |
| 161413 | 2054664738 | K153045 | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator | BXN | 2016-05-13 |
| 161413 | 1325319072 | K151959 | AirLife Infant Single Limb Heated Wire Circuit | BZE | 2016-01-20 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| CAF | 33 | 2013-04-25 |
| BTT | 17 | 2023-08-10 |
| CAH | 16 | 2012-12-06 |
| CCK | 15 | 2019-05-23 |
| BTM | 15 | 2008-10-15 |
| BYE | 9 | 2011-09-12 |
| BZE | 8 | 2017-09-14 |
| BTR | 8 | 2012-05-11 |
| KNT | 5 | 2010-08-03 |
| DXQ | 5 | 2006-07-25 |
| BZD | 4 | 2007-02-23 |
| BZC | 3 | 2019-08-16 |
| CAP | 3 | 2012-05-24 |
| BTO | 3 | 2011-03-24 |
| KDH | 3 | 1997-10-27 |
| BTL | 2 | 2018-11-16 |
| BSJ | 2 | 2017-10-13 |
| BXN | 2 | 2016-05-13 |
| NVP | 2 | 2013-06-05 |
| BSK | 2 | 2011-07-22 |
| CBP | 2 | 2003-04-22 |
| NHK | 2 | 2002-02-11 |
| BTY | 2 | 1994-11-22 |
| BZR | 2 | 1993-07-23 |
| CCQ | 2 | 1987-04-01 |
| DSA | 1 | 2017-06-22 |
| MNR | 1 | 2016-04-15 |
| HLJ | 1 | 2013-10-30 |
| FMT | 1 | 2012-09-14 |
| CBK | 1 | 2011-08-12 |
| CBI | 1 | 2010-03-11 |
| EOQ | 1 | 2009-05-22 |
| FPA | 1 | 2008-12-30 |
| FRO | 1 | 2008-12-18 |
| EZL | 1 | 2008-10-08 |
| DQA | 1 | 2007-08-13 |
| NFB | 1 | 2003-05-02 |
| JOH | 1 | 1998-11-13 |
| LHI | 1 | 1997-03-18 |
| CAI | 1 | 1993-07-23 |
Sunmed, LLC
SUNMED LLC
SUNMED
Sunmed, Inc.
SUNMED, INC.
SUNMED, INC.
SUNMED, INC.
2026-03-19
2026-02-27
2026-02-18
2026-02-18
2026-02-18
2026-02-11
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