FDA.reportPublic FDA data

MEDLINE

Primary DI
10197344149544
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
10043342RH
Catalog number
10043342RH
Device description
BW ACUNAV GE ULTRASOUND CATH 10FR X 90CM
Published
2025-09-08
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
OWQReprocessed intravascular ultrasound catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWQReprocessed Intravascular Ultrasound CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243101000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243101000Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)Surgical Instrument Service and Savings, Inc.2025-03-10OWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10197344149544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019734414954410197344149544

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular ultrasound imaging catheter, reprocessedA flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes a single or an array of transducer element(s). This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197344039791MEDLINEHNX22075HNX220752024-10-11
10197344039807MEDLINEHNX22100HNX221002024-10-11
10888277348226MEDLINEMDS630S2MDS630S22026-07-29
10888277699472MEDLINEDYND300010SDYND300010S2026-07-29
10888277699489MEDLINEDYND300015SDYND300015S2026-07-29
10888277699496MEDLINEDYND300020SDYND300020S2026-07-29
10888277699502MEDLINEDYND300025SDYND300025S2026-07-29
10888277699533MEDLINEDYND300050SDYND300050S2026-07-29
10888277701588MEDLINEMSC9912EPMSC9912EP2025-09-24
10888277701595MEDLINEMSC9918EPMSC9918EP2025-09-24
10888277701618MEDLINEMSC9945EPMSC9945EP2025-09-24
10888277701625MEDLINEMSC9948EPMSC9948EP2025-09-24
10888277701632MEDLINEMSC9966EPMSC9966EP2025-09-24
10888277701649MEDLINEMSC99812EPMSC99812EP2025-09-24
30193489103964MEDLINE1202YLW3AOS2026-07-28
30193489103971MEDLINE1202YLW3XL2026-07-28
10197344216123MEDLINESSBCS21GLSSBCS21GL2026-07-24
10197344219575MEDLINEMDS99905MDS999052026-07-24
10653160391326MEDLINEEBSI1865EBSI18652026-07-24
30193489017742MEDLINE6651CBL22X16651CBL22X12026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888551045735Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter For Use on GE SystemSTERILMED, INC.OWQ2026-07-06
10888551045742Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter For Use on GE SystemSTERILMED, INC.OWQ2026-07-06
10888551045759Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter For Use on Siemens SystemSTERILMED, INC.OWQ2026-07-06
10888551045766Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter For Use on Siemens SystemSTERILMED, INC.OWQ2026-07-06
10841898137273N/AINNOVATIVE HEALTH LLCOWQ2026-06-01
10841898137280N/AINNOVATIVE HEALTH LLCOWQ2026-06-01
10841898137174N/AINNOVATIVE HEALTH LLCOWQ2026-05-07
10841898137266N/AINNOVATIVE HEALTH LLCOWQ2026-05-07
10197344019557MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-10-15
10197344026500MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-10-15
10197344026517MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-10-15
10197344149537MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-09-08
10197344157303MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-07-11
10197344157280MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-07-08
10197344157273MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-07-08
20197344157287MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-07-08
10197344157297MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-07-08
00850044399130NES Reprocessed Visions PV .035 Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399147NES Reprocessed Visions PV .014P RX Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399154NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399161NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Short TipNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399208NES Reprocessed .014 Stryker CatheterNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399215NES Reprocessed Eagle Eye Platinum Long Tip StrykerNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399222NES Reprocessed Eagle Eye Platinum Short Tip StrykerNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399239NES Reprocessed .035 Stryker CatheterNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399178NES Reprocessed Visions PV .018 Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOWQ2025-05-19
07613327664089Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OWQ2025-02-11
07613327664096Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OWQ2025-02-11
07613327664102Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OWQ2025-02-11
07613327664119Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OWQ2025-02-11