FDA.report

Silicone Thoracic Drain, RF Type

Primary DI
04710961936244
Brand
Silicone Thoracic Drain, RF Type
Company
FORTUNE MEDICAL INSTRUMENT CORP.
Model
2018-0540
Published
2021-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GBSCatheter, Ventricular, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GBSCatheter, Ventricular, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14710961936241PrimaryGS10
04710961936244Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1471096193624114710961936241
04710961936244047109619362444710961936244

GMDN Terms

TermDefinition
Pleural catheterA sterile, tube designed to be inserted through an intercostal space and into the pleural cavity to establish a channel for the removal of fluid (pleural effusion, blood, chyle), air (pneumothorax), or pus (empyema) to permit full expansion of the lungs typically after surgery or chest trauma. It is typically used with a pleural drainage system that uses a low negative pressure through the drain lumen. Often referred to as a chest tube, it is typically made of silicone and is available in various designs, shapes, and sizes; it may include disposable devices dedicated to catheter introduction, however it does not include fluid collection bags/containers. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
656763489
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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04710961935025Silicone Flat Drain2014-01322022-01-31
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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
27290110065984Front1 Health PartnersDEGANIA SILICONE LTDGBS2024-02-20
27290110065991Front1 Health PartnersDEGANIA SILICONE LTDGBS2024-02-20
27290110066004Front1 Health PartnersDEGANIA SILICONE LTDGBS2024-02-20
27290110066011Front1 Health PartnersDEGANIA SILICONE LTDGBS2024-02-20
27290110066028Front1 Health PartnersDEGANIA SILICONE LTDGBS2024-02-20
04710961935964Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961935971Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961935988Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961935995Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936008Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936015Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936022Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936039Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936046Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936053Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936060Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936077Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936084Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936091Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936107Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936121Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936138Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936145Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936152Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936169Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936176Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936183Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936190Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936206Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
04710961936213Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15