FDA.reportPublic FDA data

C3 WAVE SYSTEM

Primary DI
00884908133400
Brand
C3 WAVE SYSTEM
Company
Medical Components, Inc.
Model
MRC3S01US
Catalog number
MRC3S01US
Device description
C3 WAVE NAVIGATION SYSTEM W/IPAD®
Published
2018-05-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LJSCatheter, intravascular, therapeutic, long-term greater than 30 days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50884908133405PackageGS11Not in Commercial Distribution
00884908133400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088490813340550884908133405
00884908133400008849081334008849081334000884908133400

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheter navigation system, electrocardiographicAn assembly of noninvasive devices intended to use electrocardiographic (ECG) data to assist guidance and positioning of a central venous catheter [e.g., peripherally-inserted central catheter (PICC), central venous catheter (CVC), haemodialysis catheter]. It includes a portable battery-powered control unit, ECG cable(s), and ECG lead(s). The catheter (not included) is used as an intravascular electrode, with the guidewire or intraluminal saline used as a conductor. The control unit processes ECG signals and sends them to a separate off-the-shelf device (e.g., smartphone), whereby intravascular ECG changes indicate catheter position typically in conjunction with skin surface ECG data.

Contacts#

Phone, Email table
PhoneEmail
+1(215)256-4201clinical@medcompnet.com

Regulatory Flags#

DUNS number
038000253
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884908034646Pro-Line® CTMR280372012015-10-22
00884908189674MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641501DMC6415012026-08-08
00884908189681MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641502DMC6415022026-08-08
00884908189698MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641503DMC6415032026-08-08
00884908189704MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641504DMC6415042026-08-08
00884908189711MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641505DMC6415052026-08-08
00884908189728MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641506DMC6415062026-08-08
00884908166330T-3 Triple Lumen CTMC013505MC0135052026-07-24
00884908185157MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDTHD155165DTHD1551652025-11-27
00884908092752T-3 Triple Lumen CTMC0135022015-10-23
00884908092769T-3 TRIPLE LUMEN CTMC0135032016-02-23
00884908016901GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIREG130NG130N2018-10-06
00884908105254GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIREMR1900202017-11-28
00884908105278GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIREMR1900402017-12-02
00884908145090GALT GUIDEWIREGALT GUIDEWIREDMR190040DMR1900402019-09-04
00884908136630DUO-FLOW® SIDE X SIDEAS0914151AS09141512026-05-13
00884908136647DUO-FLOW® SIDE X SIDEAS0914201AS09142012026-05-13
00884908136654DUO-FLOW® SIDE X SIDEAS0914241AS09142412026-05-13
00884908136661DUO-FLOW® SIDE X SIDEAC0914151AC09141512026-05-13
00884908136678DUO-FLOW® SIDE X SIDEAC0914201AC09142012026-05-13

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