FDA.reportPublic FDA data

N/A

Primary DI
10841898131561
Brand
N/A
Company
INNOVATIVE HEALTH LLC
Model
N/A
Catalog number
D138503
Device description
CARTO VIZIGO Bi-Directional Guiding Sheath, 71 cm
Published
2022-04-13
Public version status
New
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
PNEReprocessed Catheter Introducer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNEReprocessed Catheter IntroducerCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212165000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212165000Reprocessed Carto Vizigo Bi-Directional Guiding SheathInnovative Health, LLC2022-03-10PNE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841898131561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084189813156110841898131561

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, reprocessedA sterile, flexible, single-lumen tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter or lead (e.g., pacing lead, balloon dilatation catheter) through its lumen, within the vascular system. It may be rigid or flexible, non-steerable or steerable, and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, and is not a microcatheter (i.e., not intended to access superselective small vessels). It may include a disposable percutaneous introduction set. This is a previously used single-use device that has been processed for an additional single-use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity18 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-400-3740regulatory@innovative-health.com

Regulatory Flags#

DUNS number
015575953
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841898137273N/AN/A116574842026-06-01
10841898137280N/AN/A116574852026-06-01
10841898137174N/AN/A115108262026-05-07
10841898137266N/AN/A115108252026-05-07
10841898137297N/AN/AVXW-35-230-J2026-05-07
10841898137303N/AN/AVXW-35-180-J2026-05-07
10841898137310N/AN/AVXW-35-230-P2026-05-07
10841898137327N/AN/AVXW-35-180-P2026-05-07
10841898137587N/AN/AVXW-CFD-180J2026-05-07
10841898137594N/AN/AVXW-CFD-180P2026-05-07
10841898137600N/AN/AVXW-CFD-230P2026-05-07
10841898137617N/AN/AVXW-CWM-180J2026-05-07
10841898137624N/AN/AVXW-CWM-180P2026-05-07
10841898137631N/AN/AVXW-CWM-230P2026-05-07
10841898137242N/AN/AD1337032026-04-17
10841898123214N/AN/A104392362018-11-12
10841898123221N/AN/A104390722018-11-12
10841898123238N/AN/A104390112018-11-12
10841898123245N/AN/A104385772018-11-12
10841898110108N/AN/A101359362016-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841898131547N/AINNOVATIVE HEALTH LLCPNE2022-04-13
10841898131554N/AINNOVATIVE HEALTH LLCPNE2022-04-13
10841898130144N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130151N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130168N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130175N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130182N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130199N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130205N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130212N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898120244N/AINNOVATIVE HEALTH LLCPNE2019-03-06
10841898128172N/AINNOVATIVE HEALTH LLCPNE2019-02-02
10841898128196N/AINNOVATIVE HEALTH LLCPNE2019-02-02
10841898120251N/AINNOVATIVE HEALTH LLCPNE2018-05-01
10841898120268N/AINNOVATIVE HEALTH LLCPNE2017-10-16
10841898120275N/AINNOVATIVE HEALTH LLCPNE2017-10-16
10841898120282N/AINNOVATIVE HEALTH LLCPNE2017-10-16
10888551044912NASTERILMED, INC.PNE2016-09-22
10888551044929NASTERILMED, INC.PNE2016-09-22
10888551044950NASTERILMED, INC.PNE2016-09-22