Map-iT

Primary DI
00818083016364
Brand
Map-iT
Company
ACCESS POINT TECHNOLOGIES, INC.
Model
903711
Catalog number
903711
Device description
STR, 4 electrode, MPD-CS-L, 5mm electrode spacing
Published
2018-11-05
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

Related Records

Product Codes

CodeName
DRFCatheter, Electrode Recording, Or Probe, Electrode Recording

Product Code Classifications

CodeDeviceSpecialtyClass
DRFCatheter, Electrode Recording, Or Probe, Electrode RecordingCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00818083016364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00818083016364008180830163648180830163640818083016364

GMDN Terms

TermDefinition
Catheter-tip electrodeAn electrical conductor located at one end of an appropriate flexible catheter (not included) which is inserted into the chambers of the heart in order for the electrode to detect the presence of certain indicators to measure cardiac output. The relayed signals from the electrode can help the operator determine the presence of left-to-right heart shunt. The electrical conductor may also be used to characterize the electrical activity of the heart. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge5French
Length110Centimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
128599565
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
false
Sterilization required before use
false

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