External Drainage Set
- Primary DI
- 10381780035565
- Brand
- External Drainage Set
- Company
- INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
- Model
- 910120A
- Catalog number
- 910120A
- Device description
- The External Drainage Set (EDS) consists of: an extension tubing line with a T fitting and a four-way stopcock; a one-piece drainage tube assembly, including a patient line with a T fitting, a tubing, an antireflux valve, a 75 ml cylinder and a drainage tubing; a drainage bag with female luer lock connector, a suspension hook and a hydrophobic filter; a 350 mm H2O drainage pressure scale. A Lumbar Catheter Accessory Kit (LCAK).
- Published
- 2015-10-01
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Contact Domains
Product Codes
| Code | Name |
|---|---|
| JXG | Shunt, central nervous system and components |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | Neurology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10381780035565 | Primary | GS1 | 0 | |
| M272910120A1 | Secondary | HIBCC | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10381780035565 | 10381780035565 |
GMDN Terms
| Term | Definition |
|---|---|
| Lumbar cerebrospinal fluid drainage catheterization kit | A collection of sterile devices intended for short-term percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column to drain cerebrospinal fluid (CSF), and/or other fluids of similar physical characteristics, as a means of reducing CSF volume and intracranial pressure (ICP). It includes a spinal infusion/drainage catheter and devices intended for catheter insertion (e.g. Tuohy needle, suture, guidewire) and CSF collection (e.g., drip chamber, drainage bag, tubing set, filter). This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit). |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(800)654-2873 | custsvcnj@integralife.com |
Regulatory Flags
- DUNS number
- 531408342
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10381780035602 | Integral Drainage Set | 910410B | 910410B | 2015-10-01 |
| M2729105001 | Integra® | 910500 | 2016-08-08 | |
| 10381780034247 | Lumbar Catheter | 951103 | 951103 | 2015-10-01 |
| 10381780034582 | CSF Reservoir | 999301 | 999301 | 2015-10-01 |
| 10381780034599 | CSF Reservoir | 999302 | 999302 | 2015-10-01 |
| 10381780034605 | CSF Reservoir | 999303 | 999303 | 2015-10-01 |
| 10381780034612 | CSF Reservoir | 999304 | 999304 | 2015-10-01 |
| M27217185C121 | Integra® | 17185C12 | 2016-08-12 | |
| M27217185C161 | Integra® | 17185C16 | 2016-08-12 | |
| M27217185C321 | Integra® | 17185C32 | 2016-08-12 | |
| M27217185C481 | Integra® | 17185C48 | 2016-08-12 | |
| M27217185C641 | Integra® | 17185C64 | 2016-08-12 | |
| M27240M191 | Integra® | 40M19 | 2016-08-12 | |
| M27240M201 | Integra® | 40M20 | 2016-08-12 | |
| M27240M411 | Auragen™ | 40M41 | 2016-08-08 | |
| M27240M421 | Auragen™ | 40M42 | 2016-08-08 | |
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| M27240M451 | Auragen™ | 40M45 | 2016-08-08 | |
| M27240M461 | Auragen™ | 40M46 | 2016-08-08 | |
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