FDA.reportPublic FDA data

TVC Controller Sterile Barrier

Primary DI
00857595006005
Brand
TVC Controller Sterile Barrier
Company
Nipro Vascular Innovations Americas, Inc.
Model
TVC-MC8-B1
Catalog number
TVC-MC8-B1
Device description
Individual Sterile Barrier for TVC-MC8 or TVC-MC9 System Controller
Published
2016-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
OGZCatheter, Intravascular, Plaque Morphology Evaluation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
OGZCatheter, Intravascular, Plaque Morphology EvaluationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141682000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141682000TVC IMAGING SYSTEM, TVC INSIGHT CATHETERInfraredx, Inc.2014-11-24OGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857595006012PackageGS15In Commercial Distribution
00857595006005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857595006012008575950060128575950060120857595006012
00857595006005008575950060058575950060050857595006005

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length96Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-680-7339customerservice@infraredx.com

Regulatory Flags#

DUNS number
124065421
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857595006234Dualpro™ IVUS+NIRS Imaging Catheter Kit TVC-C195-42 TVC-C195-42 2018-07-11
00857595006494Dualpro™ IVUS+NIRS Imaging Catheter KitTVC-C195-42TVC-C195-422024-11-25
00857595006166Makoto Integrated Intravascular Imaging System™TVC-MC10iTVC-MC10i2022-11-11
00857595006180Infraredx Clarispro™ HD-IVUS Imaging Catheter KitTVC-E195-42 TVC-E195-42 2022-11-11
04543660023485GM-30 Accessory KitGLGMN-YOK0E2022-02-03
04543660023492GM-30 Accessory KitGLGMF-YOK0E2022-02-03
04543660023508GM-30 Accessory KitGLGMN-YOK0A2022-02-03
04543660023515GM-30 Accessory KitGLGMF-YOK0A2022-02-03
04543660022648GM-30 Inflation Device GM-30N GM-30N2021-03-05
04543660022655GM-30 Inflation Device GM-30NFGM-30NF2021-03-05
04543660022662GM-30 Inflation Device GM-30NLGM-30NL2021-03-05
04543660022334OKAY® II Y-Connector SetYOK0A2019-10-28
04543660022341OKAY® II Y-ConnectorYOK0B2019-10-28
04543660022358OKAY® II Y-Connector Set with Extension TubeYOK0E2019-10-28
00857595006203TVC Insight™ TVC-C195-20TVC-C195-202016-09-15
00857595006210TVC Insight™ TVC-C195-22TVC-C195-222016-09-15
00857595006227TVC Insight XB™TVC-C195-32TVC-C195-322016-09-15
00857595006401TVC Imaging System™TVC-MC8TVC-MC8 2016-09-15
00857595006418TVC Imaging System™TVC-MC8TVC-MC82016-09-15
00857595006425TVC Imaging System™TVC-MC9TVC-MC92018-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYO2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SIYO2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
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
00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00198953078747LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
00198953113493LOGIQGE Ultrasound Korea Ltd.IYO2026-01-21
00841436126311Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2025-12-31
00195278439352LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00195278439369LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00198953042731LOGIQGE Ultrasound Korea Ltd.IYO2025-12-05
00198953042748LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05