FDA.reportPublic FDA data

C-View® Lite System

Primary DI
00859589006008
Brand
C-View® Lite System
Company
CARROT MEDICAL, LLC
Model
100500
Catalog number
100500
Device description
The C-View® Lite System enables the interventional suite to utilize video integration from multiple modality inputs.
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXJDisplay, Cathode-Ray Tube, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXJDisplay, Cathode-Ray Tube, MedicalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083321000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083321000CARDIO-VIEWCurlview Igt, LLC2008-11-26DXJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859589006008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859589006008008595890060088595890060080859589006008

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-492-3533service@carrotmedical.com

Regulatory Flags#

DUNS number
832211366
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859589006046C-View® Platinum System1008001008002019-05-23
00859589006015C-View® Plus System1006001006002016-09-29
00859589006022C-View® Pro System1003001003002016-09-29
00859589006039C-View® Pro-S System1004001004002016-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415334058460BarcoBarco NVDXJ2026-11-03
05415334059122BarcoBarco NVDXJ2026-11-03
05415334062573BarcoBarco NVDXJ2026-11-03
05415334062993BarcoBarco NVDXJ2026-11-03
05415334062412Nexxis ORBarco NVDXJ2026-04-28
04251303302278CuratOREIZO GmbHDXJ2026-03-02
00195278343383CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DXJ2026-02-11
05415334053458BarcoBarco NVDXJ2025-06-04
05415334053472BarcoBarco NVDXJ2025-06-04
05415334053663BarcoBarco NVDXJ2025-06-04
05415334053670BarcoBarco NVDXJ2025-06-04
10889483575710Vital Signs™AirLife Finland OyDXJ2025-03-31
10889483575734Vital Signs™AirLife Finland OyDXJ2025-03-31
10889483575772Vital Signs™AirLife Finland OyDXJ2025-03-31
05415334050815Nexxis ORBarco NVDXJ2024-02-22
05415334050822Nexxis ORBarco NVDXJ2024-02-22
05415334050839Nexxis ORBarco NVDXJ2024-02-22
10193489385625Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXJ2023-06-08
40193489385626Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXJ2023-06-08
05415334037625Nexxis ORBarco NVDXJ2023-05-25
05415334037632Nexxis ORBarco NVDXJ2023-05-25
05415334037687Nexxis ORBarco NVDXJ2023-05-25
05415334042346Nexxis ORBarco NVDXJ2023-05-25
06970438060003BIGTIDEShenyang Torch-Bigtide Digital Technology Co., Ltd.DXJ2022-09-05
06970438060065BIGTIDEShenyang Torch-Bigtide Digital Technology Co., Ltd.DXJ2022-09-05
05415334039124Nexxis ORBarco NVDXJ2022-07-11
05415334039131Nexxis ORBarco NVDXJ2022-07-11
10884450568658High Pressure Tubing, Keep™Merit Medical Systems, Inc.DXJ2022-03-31
20884450387669High Pressure Tubing, Keep™Merit Medical Systems, Inc.DXJ2022-03-15
10884450569334Pressure Monitor TubingMerit Medical Systems, Inc.DXJ2022-03-05