N/A

Primary DI
10841898135972
Brand
N/A
Company
INNOVATIVE HEALTH LLC
Model
N/A
Catalog number
D-AVHDX-DF16
Device description
Advisor HD Grid X Mapping Catheter, SE, 110 cm
Published
2026-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K212776000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212776000Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC2021-12-20NLG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841898135972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084189813597210841898135972

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 Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
015575953
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
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
10841898137211N/AN/A4017482026-07-29
10841898137365N/AN/AVXAK93D1-DIL2026-07-10
10841898137372N/AN/AVXAK85D0-DIL2026-07-10
10841898137389N/AN/AVXAK85D1-DIL2026-07-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841898131899N/AINNOVATIVE HEALTH LLCNLG2022-04-13
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