Forsure 11110065
GUDID 20815123011444
A sterile hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes to meet the individual needs of the patient. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.
FORSURE MEDICAL PRODUCTS LLC
Basic tracheostomy tube, single-use| Primary Device ID | 20815123011444 |
| NIH Device Record Key | 2fb5a303-bd28-4047-a8a4-01ad34314a89 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Forsure |
| Version Model Number | 11110065 |
| Catalog Number | 11110065 |
| Company DUNS | 033809722 |
| Company Name | FORSURE MEDICAL PRODUCTS LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Lumen/Inner Diameter | 6.5 Millimeter |
| Lumen/Inner Diameter | 6.5 Millimeter |
| Lumen/Inner Diameter | 6.5 Millimeter |
| Lumen/Inner Diameter | 6.5 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN DRY CONDITIONS AWAY FROM HEAT AND LIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN DRY CONDITIONS AWAY FROM HEAT AND LIGHT |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815123011440 [Primary] |
| GS1 | 10815123011447 [Package] Contains: 00815123011440 Package: INNER BOX [10 Units] In Commercial Distribution |
| GS1 | 20815123011444 [Package] Contains: 10815123011447 Package: MASTER CASE [100 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042684
FDA Product Code
| BTO | Tube, Tracheostomy (W/Wo Connector) |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20815123011444]
Ethylene Oxide
[20815123011444]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-11-27 |
On-Brand Devices [Forsure]
| 20815123012854 | A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas e |
| 20815123012847 | A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas e |
| 20815123012830 | A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas e |
| 20815123012823 | A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas e |
| 20815123012816 | A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas e |
| 20815123012809 | A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas e |
| 20815123012793 | A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas e |
| 20815123012786 | A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas e |
| 20815123012779 | A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas e |
| 20815123010034 | A non-sterile head covering designed as a cap intended to be worn by surgical staff during an op |
| 20815123013042 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123012137 | A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintai |
| 20815123012120 | A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintai |
| 20815123012113 | A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintai |
| 20815123012106 | A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintai |
| 20815123012090 | A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintai |
| 20815123012083 | A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintai |
| 20815123012076 | A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintai |
| 20815123012069 | A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintai |
| 20815123012052 | A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintai |
| 20815123012045 | A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintai |
| 10815123012031 | A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintai |
| 20815123012021 | A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintai |
| 20815123011802 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011796 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011789 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011772 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011765 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011758 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011741 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011734 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011727 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011710 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011703 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011697 | n armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstructe |
| 20815123011680 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011673 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011666 | Code: HDLS GMDN format icon Name: Reinforced endotracheal tube, single-use Definition: An armour |
| 20815123011659 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011642 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011635 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011628 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011611 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011604 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011598 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011581 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011574 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011567 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011550 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
| 20815123011543 | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstruct |
Trademark Results [Forsure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FORSURE 98744181 not registered Live/Pending |
Jiangsu Vango Electronic Commerce Co., Ltd. 2024-09-11 |
 FORSURE 98744172 not registered Live/Pending |
Jiangsu Vango Electronic Commerce Co., Ltd. 2024-09-11 |
 FORSURE 88881721 not registered Live/Pending |
Jiangsu Vango Electronic Commerce Co., Ltd. 2020-04-21 |
 FORSURE 77760173 3861748 Live/Registered |
Aventir Biotech 2009-06-15 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.