AMSureĀ® Single Use Saline Topical Solution
Amsino Medical Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005515211 | 3005515211 | AMSINO MEDICAL (SHANGHAI) CO., LTD. | 1 | N | 2026-01-01 | Building No. 1-3, 16, Lane 355, Huazhe Road Songjiang Export Processing Zone SHANGHAI CN 201613 |
| 3005669815 | 3005669815 | AMSINO MEDICAL (KUNSHAN) CO., LTD. | 1 | N | 2026-01-01 | 582 SHIPU LIDU ROAD, QIANDENG TOWN KUNSHAN CITY Jiangsu CN 215343 |
| 3016248619 | 3016248619 | AMSINO MEDICAL INC. | 1 | Y | 2026-01-01 | 700 Enterprise St. Aurora IL US 60504 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 109041 | 1077296686 | K992719 | AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE | KNT | 2000-01-12 |
| 25007 | 1380778498 | K992719 | AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE | KNT | 2000-01-12 |
| 25007 | 1078513104 | K951528 | AMSINO DISPOSABLE VIGINAL SPECULUM | HIB | 1995-05-11 |
| 109041 | 1955967080 | K951528 | AMSINO DISPOSABLE VIGINAL SPECULUM | HIB | 1995-05-11 |
| 25007 | 1642953274 | K220267 | AMSafe NeuFlo Needleless Connector | FPA | 2022-10-07 |
| 25007 | 1132051444 | K213522 | AMSafe Pre-Filled Normal Saline Flush Syringe | NGT | 2022-03-22 |
| 25007 | 1838174813 | K200051 | PUGGLE Enteral Feeding Pump and Feeding Set | LZH | 2020-09-25 |
| 25007 | 1763366922 | K183473 | AMSafe(R) Pre-Filled Normal Saline Flush Syringe | NGT | 2019-07-12 |
| 25007 | 1713717421 | K181814 | AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water | EZL | 2018-09-04 |
| 109041 | 1654640570 | K181445 | AMSure Hydrophilic Intermittent Catheter | EZD | 2018-10-01 |
| 25007 | 1088359756 | K181423 | AMSure Sterile Water, and Sterile Normal Saline for Wound Flush | FRO | 2018-09-07 |
| 25007 | 1769601589 | K173665 | AMSafe Sure-Lok Needle-Free Connector | FPA | 2018-09-05 |
| 25007 | 2045617326 | K171857 | AMSureĀ® Enteral Feeding Syringe with ENFit Tip | PNR | 2018-03-30 |
| 25007 | 1145602924 | K101958 | AMSINO I.V. ADMINISTRATION AND EXTENSION SETS | FPA | 2010-09-29 |
| 109041 | 1891032598 | K101958 | AMSINO I.V. ADMINISTRATION AND EXTENSION SETS | FPA | 2010-09-29 |
| 109041 | 1392692868 | K101824 | AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER | EZL | 2010-09-13 |
| 109041 | 1189972689 | K093773 | AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS | FPA | 2010-03-10 |
| 25007 | 1486245923 | K093773 | AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS | FPA | 2010-03-10 |
| 109041 | 1304918356 | K091699 | AMSURE HYDROPHILIC LATEX FOLEY CATHETER | EZL | 2009-08-10 |
| 25007 | 1661215981 | K091306 | AMSURE PVC INTERMITTENT CATHETER | EZD | 2009-08-21 |
| 25007 | 1198466040 | K070873 | AMSURE BLADDER IRRIGATION SET | LJH | 2007-12-19 |
| 25007 | 1041679117 | K070411 | AMSURE NEBULIZER | CAF | 2007-10-01 |
| 25007 | 1021793739 | K061039 | AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE | FMF | 2006-06-29 |
| 109041 | 1216907108 | K051059 | AMSURE 100% SILICONE FOLEY CATHETER | EZL | 2005-06-28 |
| 25007 | 1165488156 | K050656 | AMSINO SUTURE REMOVAL KIT | MCZ | 2005-05-02 |
| 25007 | 1488696797 | K050654 | AMSINO I.V. START KIT | LRS | 2005-05-02 |
| 25007 | 1423821899 | K030664 | AMSURE FOLEY INSERTION TRAY | FCM | 2003-05-23 |
| 25007 | 1797763769 | K030293 | AMSURE RED RUBBER URETHRAL CATHETER | EYB | 2004-02-04 |
| 109041 | 1812852983 | K030293 | AMSURE RED RUBBER URETHRAL CATHETER | EYB | 2004-02-04 |
| 109041 | 1525473861 | K030120 | AMSURE FOLEY CATHETER | EZL | 2003-10-29 |
| 25007 | 2055454753 | K023276 | AMSINO TRACHEOSTOMY CARE TRAY | LRO | 2002-12-09 |
| 25007 | 1009929011 | ||||
| 25007 | 1016517725 | ||||
| 109041 | 1017160852 | ||||
| 25007 | 1027279552 | ||||
| 25007 | 1040053072 | ||||
| 25007 | 1057607629 | ||||
| 25007 | 1131178771 | ||||
| 25007 | 1148155036 | ||||
| 25007 | 1159999376 | ||||
| 109041 | 1161741211 | ||||
| 109041 | 1171056510 | ||||
| 109041 | 1185903947 | ||||
| 25007 | 1189688758 | ||||
| 109041 | 1215507452 | ||||
| 25007 | 1223466527 | ||||
| 109041 | 1232960657 | ||||
| 236993 | 1234579956 | ||||
| 25007 | 1240730385 | ||||
| 25007 | 1245496157 | ||||
| 25007 | 1273182422 | ||||
| 109041 | 1280031448 | ||||
| 109041 | 1301416002 | ||||
| 25007 | 1313804938 | ||||
| 25007 | 1317257909 | ||||
| 109041 | 1337470257 | ||||
| 25007 | 1364024636 | ||||
| 25007 | 1391456412 | ||||
| 25007 | 1394357540 | ||||
| 109041 | 1402119401 | ||||
| 25007 | 1413339567 | ||||
| 25007 | 1430840862 | ||||
| 25007 | 1441716494 | ||||
| 25007 | 1448388043 | ||||
| 25007 | 1448941659 | ||||
| 25007 | 1508440477 | ||||
| 25007 | 1543319301 | ||||
| 25007 | 1564891695 | ||||
| 109041 | 1587904287 | ||||
| 25007 | 1600063802 | ||||
| 25007 | 1618998401 | ||||
| 109041 | 1620640668 | ||||
| 25007 | 1630023089 | ||||
| 25007 | 1682758985 | ||||
| 25007 | 1696141194 | ||||
| 25007 | 1699138635 | ||||
| 109041 | 1716449085 | ||||
| 109041 | 1727709383 | ||||
| 25007 | 1799056435 | ||||
| 25007 | 1805145031 | ||||
| 25007 | 1835817562 | ||||
| 109041 | 1843656768 | ||||
| 25007 | 1850625762 | ||||
| 25007 | 1863939526 | ||||
| 25007 | 1889110022 | ||||
| 109041 | 1894912300 | ||||
| 25007 | 1902757572 | ||||
| 109041 | 1912310804 | ||||
| 25007 | 1932140712 | ||||
| 25007 | 1960274995 | ||||
| 109041 | 1975756489 | ||||
| 25007 | 1994328143 | ||||
| 25007 | 1995732903 | ||||
| 25007 | 2019048757 | ||||
| 25007 | 2020256474 | ||||
| 25007 | 2035932939 | ||||
| 236993 | 2037303688 | ||||
| 25007 | 2049740610 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FPA | 6 | 2022-10-07 |
| EZL | 5 | 2018-09-04 |
| NGT | 2 | 2022-03-22 |
| EZD | 2 | 2018-10-01 |
| EYB | 2 | 2004-02-04 |
| KNT | 2 | 2000-01-12 |
| HIB | 2 | 1995-05-11 |
| LZH | 1 | 2020-09-25 |
| FRO | 1 | 2018-09-07 |
| PNR | 1 | 2018-03-30 |
| LJH | 1 | 2007-12-19 |
| CAF | 1 | 2007-10-01 |
| FMF | 1 | 2006-06-29 |
| LRS | 1 | 2005-05-02 |
| MCZ | 1 | 2005-05-02 |
| FCM | 1 | 2003-05-23 |
| LRO | 1 | 2002-12-09 |
Amsino Medical Inc.