FDA.reportPublic FDA data

Medistim System Activation Card

Primary DI
7070554104182
Brand
Medistim System Activation Card
Company
Medistim ASA
Model
CV000441
Catalog number
CV000441
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102595000MEDISTIM VERIQC SYSTEMMedi-Stim Asa2010-12-27DPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
7070554104182PackageGS15In Commercial Distribution
07070554104175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
7070554104182070705541041827070554104182
07070554104175070705541041757070554104175

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular ultrasound imaging systemAn assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static or real-time cardiac specific imaging applications used to diagnose anatomical defects of the heart, determine blood flow characteristics and functional/anatomical problems associated with myocardial infarction. It is used to generate ultrasound pulses, direct them to a target area, detect the echoes, and process the resulting information to produce and display static or dynamic two or three-dimensional (3-D) images.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
519521751
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
07070554100818Medistim QuickFIT TTFM probePS100032PS1000322016-09-15
07070554100825Medistim QuickFIT TTFM probePS100042PS1000422016-09-15
07070554100832Medistim QuickFIT TTFM probePS100052PS1000522016-09-15
07070554100849Medistim QuickFIT TTFM probePS101012PS1010122016-09-15
07070554100856Medistim QuickFIT TTFM probePS100072PS1000722016-09-15
07070554100955Medistim Vascular TTFM probePV100061PV1000612016-09-15
07070554100962Medistim Vascular TTFM probePV100062PV1000622016-09-15
07070554100979Medistim Vascular TTFM probePV100081PV1000812016-09-15
07070554100986Medistim Vascular TTFM probePV100082PV1000822016-09-15
07070554100993Medistim Vascular TTFM probePV100141PV1001412016-09-15
07070554101006Medistim QuickFIT TTFM probePS101011PS1010112016-09-15
07070554101020Medistim Vascular TTFM probePV100101PV1001012016-09-15
07070554101044Medistim Vascular TTFM probePV100121PV1001212016-09-15
07070554101051Medistim Vascular TTFM probePV100122PV1001222016-09-15
07070554101068Medistim Vascular TTFM probePV100161PV1001612016-09-15
07070554101075Medistim Vascular TTFM probePV100162PV1001622016-09-15
07070554101082Medistim Vascular TTFM probePV100142PV1001422016-09-15
07070554101112Medistim Vascular TTFM probePV101011PV1010112016-09-15
07070554101129Medistim Vascular TTFM probePV100021PV1000212016-09-15
07070554101136Medistim Vascular TTFM probePV100031PV1000312016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841517112684C5-1FUJIFILM SONOSITE, INC.IYO2026-08-07
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126212Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126229Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126328Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGIYO2026-07-24
00841436122672Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125338Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125819Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436126281Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436126304Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00840432200216BladderScan®VERATHON INCIYO2026-07-22
00841517112011iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
06938396440008SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2026-07-10
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYO2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.IYO2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.IYO2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.IYO2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10