FDA.reportPublic FDA data

Curaplex

Primary DI
00812574026221
Brand
Curaplex
Company
TRI-ANIM HEALTH SERVICES, INC.
Model
301-005-10010
Device description
HANDLE,SUCTION,YANKAUER,STRAIGHT TIP,W/O CONTROL VENT,STERILE 50/CA
Published
2017-02-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JOLCATHETER AND TIP, SUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812574026573PackageGS150Not in Commercial Distribution
00812574026221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812574026573008125740265738125740265730812574026573
00812574026221008125740262218125740262210812574026221

GMDN Terms#

Term, Definition table
TermDefinition
Pleural catheterA 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 table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
010712461
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812574025804Curaplex301-P3000EA2016-12-16
00812574025828Curaplex301-P3001EA2016-12-16
00812574025842Curaplex301-P3002EA2016-12-16
00818834020466Curaplex301-180U301-180U2019-02-10
00818834020473Curaplex301-181U301-181U2019-02-10
00818834020480Curaplex301-182U301-182U2019-02-10
00818834020510Curaplex301-189U301-189U2019-02-10
00818834020718Curaplex301-104301-1042019-02-10
00818834020817Curaplex301-122EA301-122EA2019-02-10
00818834020909Curaplex301-170EA301-170EA2019-02-10
00818834020923Curaplex301-180EA301-180EA2019-02-10
00818834020954Curaplex301-181EA301-181EA2019-02-10
00818834020961Curaplex301-182EA301-182EA2019-02-10
00818834020978Curaplex301-183301-1832019-02-10
00818834020985Curaplex301-184301-1842019-02-10
00818834020992Curaplex301-189301-1892019-02-10
00818834021005Curaplex301-191301-1912019-02-10
00812574025811Curaplex301-P3000EA2016-12-14
00812574025835Curaplex301-P3001EA2016-12-14
00812574025859Curaplex301-P3002EA2016-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00827002606623OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606630OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606647OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606654OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606661OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606678OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606685OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606692OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606708OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606715OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606722OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606739OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606746OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606753OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606760OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606777OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606784OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606791OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606807OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606814OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606821OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002613553CookCOOK INCORPORATEDJOL2026-10-22
00190776436384MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436391MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436407MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436414MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436421MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436469MilleniumAvalign Technologies, Inc.JOL2026-10-08
00190776436476MilleniumAvalign Technologies, Inc.JOL2026-10-08