Drentech Pump 100 ml Round Drainage w/trocar Fr 15
- Primary DI
- 08034139290874
- Brand
- Drentech Pump 100 ml Round Drainage w/trocar Fr 15
- Company
- REDAX SPA
- Model
- 10483
- Catalog number
- 10483
- 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 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 |
|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | General, Plastic Surgery | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 18034139290871 | Package | GS1 | 10 | In Commercial Distribution |
| 08034139290874 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 18034139290871 | 18034139290871 | |
| 08034139290874 | 08034139290874 | 8034139290874 |
GMDN Terms#
| Term | Definition |
|---|---|
| Closed-wound drain, non-bioabsorbable | A 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 | Condition |
|---|---|---|---|
| Storage Environment Humidity | 10 Percent (%) Relative Humidity | 90 Percent (%) Relative Humidity | |
| Storage Environment Temperature | 0 Degrees Celsius | 60 Degrees Celsius |
Contacts#
| Phone | |
|---|---|
| +17868187337 | christian.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 | Catalog | Published |
|---|---|---|---|---|
| 08034139292809 | Thoracic Catheter, Straight Fr 12 | 20812 | 20812 | 2021-05-04 |
| 08034139292816 | Thoracic Catheter, Straight Fr 15 | 20815 | 20815 | 2021-05-05 |
| 08034139292823 | Thoracic Catheter, Straight Fr 18 | 20818 | 20818 | 2021-05-07 |
| 08034139292830 | Thoracic Catheter, Straight Fr 21 | 20821 | 20821 | 2021-05-07 |
| 08034139292847 | Thoracic Catheter, Straight Fr 24 | 20824 | 20824 | 2021-05-07 |
| 08034139292854 | Thoracic Catheter, Straight Fr 28 | 20828 | 20828 | 2021-05-05 |
| 08034139292861 | Thoracic Catheter, Straight Fr 30 | 20830 | 20830 | 2021-05-07 |
| 08034139292878 | Thoracic Catheter, Straight Fr 33 | 20833 | 20833 | 2021-05-07 |
| 08034139292885 | Thoracic Catheter, Straight Fr 36 | 20836 | 20836 | 2021-05-05 |
| 08034139293783 | Thoracic Catheter, Angled Fr 24 | 21824 | 21824 | 2021-05-05 |
| 08034139293790 | Thoracic Catheter, Angled Fr 28 | 21828 | 21828 | 2021-05-05 |
| 08034139293806 | Thoracic Catheter, Angled Fr 30 | 21830 | 21830 | 2021-05-07 |
| 08034139293813 | Thoracic Catheter, Angled Fr 33 | 21833 | 21833 | 2021-05-07 |
| 08034139293820 | Thoracic Catheter, Angled Fr 36 | 21836 | 21836 | 2021-05-05 |
| 08034139294506 | Flat Drain type Jackson-Pratt 3x7 mm | 24100 | 24100 | 2021-05-03 |
| 08034139294513 | Flat Drain 3/4 type Jackson-Pratt 3x7 mm w/trocar | 24101 | 24101 | 2021-05-05 |
| 08034139294520 | Flat Drain type Jackson-Pratt 3x7 mm | 24110 | 24110 | 2021-05-05 |
| 08034139294537 | Flat Drain type Jackson-Pratt 3x7 mm w/trocar | 24111 | 24111 | 2021-05-05 |
| 08034139294544 | Flat Drain 3/4 type Jackson-Pratt 4x10 mm | 24120 | 24120 | 2021-05-07 |
| 08034139294551 | Flat Drain 3/4 type Jackson-Pratt 4x10 mm w/trocar | 24121 | 24121 | 2021-05-05 |
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