FDA.reportPublic FDA data

PTS-X™

Primary DI
04046964512155
Brand
PTS-X™
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
613749
Catalog number
613749
Device description
PTSX403 PTSX BALLOON 40MM X 3CM X 80CM
Published
2016-08-09
Public version status
Update
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
MJNCatheter, intravascular occluding, temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJNCatheter, Intravascular Occluding, TemporaryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041306000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041306000NUMED PTS X SIZING BALLOON CATHETERNuMED, Inc.2004-06-10MJN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964512155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964512155040469645121554046964512155

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac sizing catheterA sterile flexible tube with an inflatable balloon at the distal end designed for use in a patient with a cardiovascular defect wherein accurate measurement of the defect is important to select the appropriately sized occlusion device. It is typically designed to pass over a guidewire and it will have radiopaque marker bands along it distal end to assist in placement using fluoroscopy. It is made of plastic materials and metal [e, g, platinum (Pt) for the bands] and is available in a variety of designs and sizes. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00KEEP DRY
Special Storage Condition, Specify00ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, Specify00Store at room temp

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)836-2228GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
784259751
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964309809Micro-Access Elite®6133406133402016-08-09
04046964309823Micro-Access Elite®6133416133412016-08-09
04046964309847Micro-Access Elite®6133426133422016-08-09
04046964309861Micro-Access Elite®6133436133432016-08-09
04046964309885Micro-Access Elite®6133446133442016-08-09
04046964309908Micro-Access Elite®6133456133452016-08-09
04046964309922Micro-Access Elite®6133466133462016-08-09
04046964309946Micro-Access Elite®6133476133472016-08-09
04046964309960Micro-Access Elite®6133486133482016-08-09
04046964309977Micro-Access Elite®6133496133492016-08-09
04046964310003Micro-Access Elite®6133506133502016-08-09
04046964310027Micro-Access Elite®6133516133512016-08-09
04046964310041Micro-Access Elite®6133526133522016-08-09
04046964310065Micro-Access Elite®6133536133532016-08-09
04046964310089Micro-Access Elite®6133546133542016-08-09
04046964310102Micro-Access Elite®6133556133552016-08-09
04046964310126Micro-Access Elite®6133566133562016-08-09
04046964310140Micro-Access Elite®6133576133572016-08-09
04046964310164Micro-Access Elite®6133586133582016-08-09
04046964310188Micro-Access Elite®6133596133592016-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850001105118Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.MJN2025-06-20
00842429117545SCEPTERMicrovention, Inc.MJN2025-04-30
00842429117552SCEPTERMicrovention, Inc.MJN2025-04-30
00842429117569SCEPTERMicrovention, Inc.MJN2025-04-30
00842429117583SCEPTERMicrovention, Inc.MJN2025-04-30
00842429106884Balloon CatheterMicrovention, Inc.MJN2025-04-22
00842429106891Balloon CatheterMicrovention, Inc.MJN2025-04-22
00842429106907Balloon CatheterMicrovention, Inc.MJN2025-04-22
00842429106945Balloon CatheterMicrovention, Inc.MJN2025-04-22
10628678061054COBRA-OS®Front Line Medical Technologies Inc.MJN2024-03-22
10628678061061Syringe, 10 mLFront Line Medical Technologies Inc.MJN2024-03-22
B090LRN0590LANDMARKZIEN MEDICAL TECHNOLOGIES, INC.MJN2024-01-23
B090LRN0591LANDMARKZIEN MEDICAL TECHNOLOGIES, INC.MJN2024-01-23
10628678061009COBRA-OS™Front Line Medical Technologies Inc.MJN2023-08-25
10628678061016COBRA-OS™Front Line Medical Technologies Inc.MJN2023-08-25
10628678061023Syringe, 10 mLFront Line Medical Technologies Inc.MJN2023-08-25
20763000293424Cadence ™ Precision Injector Thread 1 mL SyringeMicro Therapeutics, Inc.MJN2022-12-23
00850001105057Prytime Medical Devices Inc.Prytime Medical Devices, Inc.MJN2022-12-15
00850001105064Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.MJN2022-12-15
00842429103388Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429103395Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429103401Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429103418Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429106563Balloon CatheterMicrovention, Inc.MJN2022-06-14
00853359008414SniperEmbolx, Inc.MJN2022-05-18
16286780610016COBRA-OS™Front Line Medical Technologies Inc.MJN2022-02-09
16286780610023Syringe, 10 mLFront Line Medical Technologies Inc.MJN2022-02-09
16286780610009COBRA-OS™Front Line Medical Technologies Inc.MJN2022-01-28
00853892004447Terumo Aortic BalloonQXMEDICALMJN2021-09-03