100 ml Bulb and JP Flat 3/4 fenestration 3 x 7 mm
- Primary DI
- 18034139290581
- Brand
- 100 ml Bulb and JP Flat 3/4 fenestration 3 x 7 mm
- Company
- REDAX SPA
- Model
- 10401
- Catalog number
- 10401
- 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. All the drainages have depth markings, graduated from the end of the perforated section: these markings facilitate accurate positioning of the drainage in the wound. All the silicon drainages are biocompatible and hemocompatible (in accordance with the regulations in force). All the subject products are compatible for use with gravity or suction drainage systems. The reservoir has a capacity of 100 ml and can be equipped with a collection bag. 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
- 2020-10-21
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- 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 |
|---|---|---|---|---|
| 18034139290581 | Package | GS1 | 10 | In Commercial Distribution |
| 08034139290584 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 18034139290581 | 18034139290581 | |
| 08034139290584 | 08034139290584 | 8034139290584 |
GMDN Terms#
| Term | Definition |
|---|---|
| Closed-wound drainage kit | A collection of sterile devices designed to remove fluids or purulent material from a closed-wound in a controlled manner. It includes a container (the receptacle or reservoir), drains/catheters, connectors, a grasping device and possibly a trocar for placing the drains/catheters into the site. The reservoir will usually be provided with graduated markers along its side to facilitate the approximate measurement of the collected fluids. 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 |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +17868187337 | christian.costantini@redax.it |
Regulatory Flags#
- DUNS number
- 338664915
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
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|---|---|---|---|---|
| 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 |
| 08034139290874 | Drentech Pump 100 ml Round Drainage w/trocar Fr 15 | 10483 | 10483 | 2021-05-04 |
| 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 |
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