FDA.reportPublic FDA data

MEDLINE

Primary DI
10197344157303
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
10439236RH
Catalog number
10439236RH
Device description
BW SOUNDSTAR ECO CATH 8FR 90CM GE
Published
2025-07-11
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
OWQReprocessed intravascular ultrasound catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWQReprocessed Intravascular Ultrasound CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250545000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250545000Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)Surgical Instrument Service and Savings, Inc.2025-06-05OWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10197344157303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019734415730310197344157303

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344149537MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-09-08
10197344149544MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-09-08
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
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
57613327664114Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OWQ2025-02-11
10841898134494N/AINNOVATIVE HEALTH LLCOWQ2024-11-06
B227RS889011NES Reprocessed .035 Stryker CatheterNORTH EAST SCIENTIFIC INCOWQ2024-08-16
B227R85900PST1NES Reprocessed Eagle Eye Platinum Short Tip StrykerNORTH EAST SCIENTIFIC INCOWQ2024-08-15
B227RS014R1NES Reprocessed .014 Stryker CatheterNORTH EAST SCIENTIFIC INCOWQ2024-08-15
B227RS85900P1NES Reprocessed Eagle Eye Platinum Long Tip StrykerNORTH EAST SCIENTIFIC INCOWQ2024-08-15
00850065047003Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R)Vein360 LLCOWQ2024-08-02
00850065047010Vein360 Reprocessed Digital Intravascular (IVUS) Reprocessed Catheter PV .018Vein360 LLCOWQ2024-08-02
00850065047027Vein360 Reprocessed Visions PV.035 Digital IVUS CatheterVein360 LLCOWQ2024-08-02
00850065047034Vein360 Reprocessed Visions PV.014P RX Digitial IVUS Catheter (014P)Vein360 LLCOWQ2024-08-02
00850065047041Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS CatheterVein360 LLCOWQ2024-08-02
00850065047058Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter Vein360 LLCOWQ2024-08-02
00860036000517Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R)Vein360 LLCOWQ2024-03-25
00860036000579Vein360 Reprocessed Visions PV.014P RX Digitial IVUS Catheter (014P)Vein360 LLCOWQ2024-03-25
00860036000586Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS CatheterVein360 LLCOWQ2024-03-25
00860036000593Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS CatheterVein360 LLCOWQ2024-03-25
10841898134418N/AINNOVATIVE HEALTH LLCOWQ2023-12-08