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

CodeName
JXGShunt, central nervous system and components

Product Code Classifications

CodeDeviceSpecialtyClass
JXGShunt, Central Nervous System And ComponentsNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780035565PrimaryGS10
M272910120A1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178003556510381780035565

GMDN Terms

TermDefinition
Lumbar cerebrospinal fluid drainage catheterization kitA 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

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)654-2873custsvcnj@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

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