70 Microdialysis Bolt Catheter 130/10, 4/pkg

Primary DI
07332699000577
Brand
70 Microdialysis Bolt Catheter 130/10, 4/pkg
Company
M DIALYSIS INC.
Model
130/10
Catalog number
P000131
Device description
Microdialysis catheter (20 kDa cut-off, 130 mm shaft length, 10 mm membrane length) for short term brain insertion using a bolt.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GWMDevice, Monitoring, Intracranial Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWMDevice, Monitoring, Intracranial PressureNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332699000577PackageGS14In Commercial Distribution
07332699000973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332699000577073326990005777332699000577
07332699000973073326990009737332699000973

GMDN Terms#

Term, Definition table
TermDefinition
Microdialysis system catheterA thin, flexible tube intended to be inserted/implanted into tissue (e.g., brain, liver, muscle) as part of a system used to monitor local tissue chemistry for the early detection of metabolic imbalances and/or cell damage, typically after surgery or during a metabolic disorder. The device has a semi-permeable membrane at its distal end for the diffusion of interstitial fluid to obtain a dialysate sample for analysis. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
824632087
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
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332699000607ISCUSflexClinical80032952016-09-24
0733269900091170 Brain Microdialysis Catheter 60/10, 4/pkg60/10P0000492016-09-24
0733269900092870 Brain Microdialysis Catheter 100/10, 4/pkg100/10P0000502016-09-24
0733269900097370 Microdialysis Bolt Catheter 130/10, 4/pkg130/10P0001312016-09-24
07332699000300Reagent KitReagentP0000112016-09-24
07332699000331Reagent Set AReagent80021632016-09-24
07332699000348Reagent Set BReagent80021642016-09-24
07332699000355Reagent Set CReagent80021652016-09-24
07332699000461Calibrator ACalibratorP0000572016-09-24
07332699000744ISCUSflexClinical80032952016-09-24
07332699000621L-P-G Reagent kitReagent80103612016-09-24
0733269900054670 Brain Microdialysis Catheter 60/10, 4/pkg60/10P0000492016-09-24
0733269900053970 Brain Microdialysis Catheter 100/10, 4/pkg100/10P0000502016-09-24
07332699000034106 Microdialysis Pump106P0000032016-09-24
07332699000058Battery 2x3V, 106 MD Pump10680017882016-09-24
07332699000072106 Syringe10680101912016-09-24
07332699000249Microvial rack 12/pkgRackP0000282016-09-24
07332699000256Microvials 250/pkg250 x MicrovialP0000012016-09-24
07332699000263Perfusion fluid CNSCNSP0001512016-09-24
07332699000287Glutamate reagent5 x Reagent, 5 x BufferP0000642016-09-24

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