FDA.reportPublic FDA data

N/A

Primary DI
10841898130373
Brand
N/A
Company
INNOVATIVE HEALTH LLC
Model
N/A
Catalog number
2ACHC
Device description
Reprocessed Achieve Catheter Connecting Cable 6.4 ft
Published
2020-06-06
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
NLHCatheter, Recording, Electrode, Reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NLHCatheter, Recording, Electrode, ReprocessedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193263000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193263000Reprocessed Achieve Catheter Connecting CableInnovative Health, LLC2020-01-24NLH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841898130373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084189813037310841898130373

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
10841898135972N/AN/AD-AVHDX-DF162026-10-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344020973MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344020980MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344021000MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043439MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043446MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043453MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043460MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043477MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043484MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043491MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043514MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043538MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043545MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043552MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043569MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043583MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043590MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043606MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043613MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043620MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043637MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043651MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043668MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043675MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043682MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043699MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043705MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043712MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043729MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043736MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15