N/A

Primary DI
10841898131899
Brand
N/A
Company
INNOVATIVE HEALTH LLC
Model
N/A
Catalog number
M004RC64S0
Device description
IntellaMap Orion High Resolution Mapping Catheter, 115 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
NLGCatheter, Intracardiac Mapping, High-Density, Reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NLGCatheter, Intracardiac Mapping, High-Density, ReprocessedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211662000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211662000Reprocessed IntellaMap Orion High Resolution Mapping CatheterInnovative Health, LLC2021-11-18NLG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841898131899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084189813189910841898131899

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping catheter, percutaneous, reprocessedA sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias and cardioversion (CV), and electrophysiology (EP) mapping. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

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
10888551045179NASTERILMED, INC.NLG2021-10-12
10888551045186NASTERILMED, INC.NLG2021-10-12
10888551045193NASTERILMED, INC.NLG2021-10-12
10888551045209NASTERILMED, INC.NLG2021-10-12
10841898130731N/AINNOVATIVE HEALTH LLCNLG2020-10-21
10841898127748N/AINNOVATIVE HEALTH LLCNLG2019-07-12
10841898127755N/AINNOVATIVE HEALTH LLCNLG2019-07-12
10841898127762N/AINNOVATIVE HEALTH LLCNLG2019-07-12
10841898127779N/AINNOVATIVE HEALTH LLCNLG2019-07-12