FDA.reportPublic FDA data

Silicone Thoracic Catheters

Primary DI
20650862148248
Brand
Silicone Thoracic Catheters
Company
Atrium Medical Corporation
Model
14824
Catalog number
14824
Device description
24 Fr Extended Length – Silicone Catheter
Published
2020-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGZAccessories, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGZAccessories, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20650862148248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2065086214824820650862148248

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge24French

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
603-880-1433customercare-US@getinge.com

Regulatory Flags#

DUNS number
051798999
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00650862122923iCast covered stent system, 12mm x 29mm x 120cmGBX12292A2026-02-18
00650862124118iCast covered stent system, 12mm x 41mm x 80cmGBX12411A2026-02-18
00650862124125iCast covered stent system, 12mm x 41mm x 120cmGBX12412A2026-02-18
00650862126112iCast covered stent system, 12mm x 61mm x 80cmGBX12611A2026-02-18
00650862126129iCast covered stent system, 12mm x 61mm x 120cmGBX12612A2026-02-18
00650862425321iCast covered stent system, 5mm x 32mm x 120cm425322026-02-18
00650862426328iCast covered stent system, 6mm x 32mm x 120cm 426322026-02-18
00650862427325iCast covered stent system, 7mm x 32mm x 120cm427322026-02-18
00650862428322iCast covered stent system, 8mm x 32mm x 120cm428322026-02-18
00650862429329iCast covered stent system, 9mm x 32mm x 120cm429322026-02-18
00650862480597iCast covered stent system, 10mm x 59mm x 80cm480592026-02-18
00650862485325iCast covered stent system, 5mm x 32mm x 80cm485322026-02-18
00650862486322iCast covered stent system, 6mm x 32mm x 80cm 486322026-02-18
00650862487329iCast covered stent system, 7mm x 32mm x 80cm 487322026-02-18
00650862488326iCast covered stent system, 8mm x 32mm x 80cm 488322026-02-18
00650862489323iCast covered stent system, 9mm x 32mm x 80cm489322026-02-18
00650862720594iCast covered stent system, 10mm x 59mm x 120cm720592026-02-18
00650862420388iCast Covered Stent System, 10mmX38mmX120cm42038420382023-06-09
00650862425161iCast Covered Stent System, 5mmX16mmX120cm42516425162023-06-09

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