SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,
ENTER MEDICAL CORPORATION
ENTER MEDICAL CORPORATION
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3003902679 | 3003902679 | ENTER MEDICAL CORPORATION | 1 | N | 2026-01-01 | No. 66-5, Yao Tzu Chu, Tsai Kung Village Hsin Kang Township Chiayi County TW 61642 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 61427 | 1374551352 | K152521 | Seal Rite Non-Rebreathing Valve | CBP | 2016-06-03 |
| 61427 | 1436862554 | K042556 | SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022, | BTM | 2005-03-11 |
| 61427 | 1024681784 | ||||
| 61427 | 1034160079 | ||||
| 61427 | 1083210013 | ||||
| 61427 | 1116172133 | ||||
| 61427 | 1151058387 | ||||
| 61427 | 1170439173 | ||||
| 61427 | 1195858903 | ||||
| 61427 | 1291969405 | ||||
| 61427 | 1394703289 | ||||
| 61427 | 1433578227 | ||||
| 61427 | 1509010441 | ||||
| 61427 | 1599409744 | ||||
| 61427 | 1609808033 | ||||
| 61427 | 1705821269 | ||||
| 61427 | 1706169955 | ||||
| 61427 | 1719380963 | ||||
| 61427 | 1750568979 | ||||
| 61427 | 2002883143 | ||||
| 61427 | 2023799814 |
Product Codes Associated With Registrations#
PMN#
GUDID#
RESERVOIR - PN-0601
2023-10-19
Seal Rite Mask - 120
2023-10-19
Catheter Mount - PN-2025
2023-10-19
Bubble Humidifier - PN-302-01
2023-10-19
Nasal Cannula - PN-2013
2023-10-19
reusable resuscitator - ENT-1022
2023-10-19
Disposable Resuscitator - ENT-1001
2023-10-19
Anaesthetic Face Mask - PN-0506
2023-10-19
Oxygen Tube - ENT-2023
2023-09-28
2M Tube - ENT-2023
2023-09-28
Breathing Circuit - ENT-2023
2023-09-28
Breathing Circuit - ENT-2023
2023-09-28
HEAD STRAP - ENT-2023
2023-09-28
LARYNGOSCOPE - A hand-held disposable device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation.
2023-06-19
Silicone mask - Silicone mask provide a method to transfer breathing oxygen gas from a storage tank to lungs
2023-06-19
Water Trap - A non-sterile device intended to be integrated within a breathing circuit
2023-06-19
Bite Block - A device intended to be inserted into a patient''s mouth to maintain oral patency during an endoscopic procedure primarily to protect the endoscope
2023-06-19
Berman Airway - A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow.
2023-06-19
Teeth Screw Driver - A mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention.
2023-06-19
mada - 1028
2015-10-14
mada - 1434
2015-10-14
mada - 1432
2015-09-08
mada - Mada-1435
2016-03-07
mada - Mada-1437
2016-03-07
Legend - RMR001R
2015-10-14
Legend - RMR002R
2015-10-14
Legend - RMR003R
2015-10-14
mada - Mada-1428
2016-03-07
mada - mada-1434
2016-03-07
mada - Mada-1436
2016-03-07
mada - Mada-1436NN
2016-03-07