FDA.report

MEDLINE

Primary DI
20197344157287
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
10439011RH
Catalog number
10439011RH
Device description
BW SOUNDSTAR ECO CATH 8FR 90CM SIEMENS
Published
2025-07-08
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

Related Records

Contact Domains

Product Codes

CodeName
OWQReprocessed intravascular ultrasound catheter

Product Code Classifications

CodeDeviceSpecialtyClass
OWQReprocessed Intravascular Ultrasound CatheterCardiovascular2

Premarket Submissions

SubmissionSupplement
K250545000

Premarket Details

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

IdentifierTypeAgencyPackage quantityStatus
20197344157287PackageGS14In Commercial Distribution
10197344157280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019734415728720197344157287
1019734415728010197344157280

GMDN Terms

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

Contacts

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

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