FDA.reportPublic FDA data

Pleura Med

Primary DI
07500463968372
Brand
Pleura Med
Company
Solomed, S.A. de C.V.
Model
Adult
Device description
Equipment to drain the pleural cavity
Published
2019-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FONBag, Drainage, With Adhesive, Ostomy
KDQBottle, Collection, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FONBag, Drainage, With Adhesive, OstomyGastroenterology, Urology1
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07500463968372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07500463968372075004639683727500463968372

GMDN Terms#

Term, Definition table
TermDefinition
Thoracic suction collection containerA device intended to be connected between a thoracic drainage catheter (not included) and a suction wall outlet, to collect fluids (e.g., blood), secretions and/or air during controlled aspiration of the pleural cavity and/or mediastinum. The device typically incorporates three graduated chambers, designed for fluid collection, water seal, and suction control, and a suction regulator, air leak indicator, and connection tubing. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
588625921
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07500463968341Sterilex1000ml2019-05-30
07500463968396FlexmarSmall2019-07-26
07502286510004FlexmarLarge2019-07-26
07502286510011Hidroderm 10 x 10 cm2019-07-26
07502286510028Hidroderm 15 x 16 cm2019-07-26
07502286510035Hidroderm 15 x 21 cm2019-07-26
07502286510042SOLOMED Disposable Surgical GownMedium Size 2020-07-17
07502286510059SOLOMED Disposable Surgical GownLarge Size2020-07-17
07502286510066SOLOMED Disposable Surgical GownExtra Large Size2020-07-17
17502286510049Bata quirúrgica SOLOMEDTalla mediana2020-07-17
17502286510056Bata quirúrgica SOLOMEDTalla grande2020-07-17
17502286510063Bata quirúrgica SOLOMEDTalla extra grande2020-07-17
07500463968389Pleura MedPediatric 2019-05-30
07500463968303Osto System Adult2019-05-30
07500463968310Osto SystemPediatric 2019-05-30
07500463968327Osto SystemNeonatal 2019-05-30
07500463968334Osto System Adult2019-05-30
07500463968358Bantex6cm2019-06-06
07500463968365Bantex8cm2019-06-06

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Primary DI, Brand, Company table
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B674WIKE1401101PerilavStiehl Tech, LLCFON2026-05-13
B674WIKE2001101PerilavStiehl Tech, LLCFON2026-05-13
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14026704911919PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911926PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911933PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911940PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
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