C3 WAVE SYSTEM

GUDID 15051684027397

C3 WAVE REMOTE BATTERY ACC

ANGIODYNAMICS, INC.

Central venous catheter navigation system, electrocardiographic
Primary Device ID15051684027397
NIH Device Record Key6dcb6529-c5de-4dd0-8d25-4f43ade87f03
Commercial Distribution StatusIn Commercial Distribution
Brand NameC3 WAVE SYSTEM
Version Model NumberMRC3S97
Company DUNS079105071
Company NameANGIODYNAMICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS115051684027397 [Secondary]
HIBCCH787MRC3S970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LJSCatheter, intravascular, therapeutic, long-term greater than 30 days

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-18
Device Publish Date2022-04-08

On-Brand Devices [C3 WAVE SYSTEM]

15051684020862C3 ECG SYSTEM - US
15051684020855C3 ECG SYSTEM W/ IPAD - US
15051684027397C3 WAVE REMOTE BATTERY ACC
15051684027380C3 WAVE HUB CHARGING BASE ACC
15051684027373C3 WAVE IPAD CASE ACCESSORY
15051684027366C3 WAVE QUICK RELEASE CLAMP
15051684027359BROTHER LABEL PRINTER
15051684027328C3 WAVE ECG LEAD SET (IEC)
15051684027311C3 WAVE HUB BATTERY ACCESSORY
15051684027274C3 POLE MOUNT KIT
15051684027267C3 WAVE CASE
15051684027243C3 WAVE REMOTE ACCESSORY
15051684027236C3 WAVE HUB ACCESSORY
H787MRC3RD0041C3 ECG CABLE ACCESSORY PACK W/MB DRAPE - US
H787MRC3RD0031C3 ACCESSORY PACK (REMOTE CVR & CLIP/CABLE) - US
H787MRC3RD0001C3 ECG CABLE ACCESSORY PACK - US
15051684027199C3 ACCESSORY PACK (REMOTE CVR & CLIP/CABLE)
15051684027168C3 ECG CABLE ACCESSORY PACK
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