Drentech Pump 100 ml Smart Drain w/trocar Fr 19

Primary DI
08034139297132
Brand
Drentech Pump 100 ml Smart Drain w/trocar Fr 19
Company
REDAX SPA
Model
10413
Catalog number
10413
Device description
The drainage system is composed of a silicone reservoir equipped with an anti-backflow valve and one or two connectors, and a drainage tube. The drainage is characterized by a section equipped with drainage grooves, together with a round section portion. The drainage has depth markings, graduated from the end of the perforated section: these markings facilitate accurate positioning of the drainage in the wound. The silicone drainage is biocompatible and hemocompatible (in accordance with the regulations in force). The subject product is compatible for use with gravity or suction drainage systems. The reservoir has a capacity of 100 ml. Thanks to the typical elasticity of silicone, the drainage suction power remains constant until the reservoir is completely full. The drainage system is a sterile and single-use device.
Published
2021-05-04
Public version status
Update
Distribution status
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
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18034139297139PackageGS110In Commercial Distribution
08034139297132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1803413929713918034139297139
08034139297132080341392971328034139297132

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drain, non-bioabsorbableA tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+17868187337christian.costantini@redax.it

Regulatory Flags#

DUNS number
338664915
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08034139292809Thoracic Catheter, Straight Fr 1220812208122021-05-04
08034139292816Thoracic Catheter, Straight Fr 1520815208152021-05-05
08034139292823Thoracic Catheter, Straight Fr 1820818208182021-05-07
08034139292830Thoracic Catheter, Straight Fr 2120821208212021-05-07
08034139292847Thoracic Catheter, Straight Fr 2420824208242021-05-07
08034139292854Thoracic Catheter, Straight Fr 2820828208282021-05-05
08034139292861Thoracic Catheter, Straight Fr 3020830208302021-05-07
08034139292878Thoracic Catheter, Straight Fr 3320833208332021-05-07
08034139292885Thoracic Catheter, Straight Fr 3620836208362021-05-05
08034139293783Thoracic Catheter, Angled Fr 2421824218242021-05-05
08034139293790Thoracic Catheter, Angled Fr 2821828218282021-05-05
08034139293806Thoracic Catheter, Angled Fr 3021830218302021-05-07
08034139293813Thoracic Catheter, Angled Fr 3321833218332021-05-07
08034139293820Thoracic Catheter, Angled Fr 3621836218362021-05-05
08034139290874Drentech Pump 100 ml Round Drainage w/trocar Fr 1510483104832021-05-04
08034139294506Flat Drain type Jackson-Pratt 3x7 mm24100241002021-05-03
08034139294513Flat Drain 3/4 type Jackson-Pratt 3x7 mm w/trocar24101241012021-05-05
08034139294520Flat Drain type Jackson-Pratt 3x7 mm24110241102021-05-05
08034139294537Flat Drain type Jackson-Pratt 3x7 mm w/trocar24111241112021-05-05
08034139294544Flat Drain 3/4 type Jackson-Pratt 4x10 mm24120241202021-05-07

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