FDA.reportPublic FDA data

CORODYN

Primary DI
04046955651702
Brand
CORODYN
Company
B. BRAUN MEDICAL INC.
Model
602268-02
Catalog number
602268-02
Device description
ANGIOGRAPHY BALLOON CATH 6FR 60CM FG
Published
2021-08-18
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
DYGCATHETER, FLOW DIRECTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYGCatheter, Flow DirectedCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955651719PrimaryGS10
04046955651702Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955651719040469556517194046955651719
04046955651702040469556517024046955651702

GMDN Terms#

Term, Definition table
TermDefinition
Coronary sinus venogram catheterA flexible tube designed for use within the coronary sinus to infuse contrast medium solution into the coronary vasculature for venogram imaging procedures. It typically consists of a double-lumen tube, one lumen for the inflation of a balloon at the distal tip and the other for the infusion of the contrast solution. It has a Luer-lock connector to connect to the solution injection device, and a stopcock to close the infusion lumen to prevent backflow. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE BETWEEN 15 - 30 °C
Special Storage Condition, Specify00STORE IN A DRY PLACE
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-2862BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags#

DUNS number
002397347
Device count
5
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046955672370Design Options®5606805606802026-05-24
04046955900268Design Options®5517695517692026-05-14
04046964308024Design Options®5517695517692016-09-23
04045928020392Design Options®5521235521232026-05-11
04045928020699Design Options®5521795521792026-05-11
04046955803125Clik-Fix®LLS-1021BLLS-1021B2023-01-06
04046955803163Clik-Fix®LLS-1024BLLS-1024B2023-01-06
04046955803194Clik-Fix®NPS-1006BNPS-1006B2022-12-22
04046955803231Clik-Fix®LLSK-1024BLLSK-1024B2023-01-06
04046955803255Clik-Fix®PCS-1011BPCS-1011B2022-12-22
04046955803286Clik-Fix®WCS-1000BWCS-1000B2023-03-13
04046955803316Clik-Fix®WCS-1003BWCS-1003B2023-03-06
04046955803347Clik-Fix®WCS-1006BWCS-1006B2023-01-06
04046955840878Clik-Fix®ECS-1000BECS-1000B2025-01-12
04046955840908Clik-Fix®ECS-2000BECS-2000B2024-12-08
04046961024811Blood Administration Set4700824700822026-05-10
04046964303326IV Administration Set4901734901732026-05-10
04046964727078EASYPUMP4434447-024434447-022016-09-23
04046964727139EASYPUMP4434455-024434455-022016-09-23
04046964183232Perifix®4150044150042016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00690103218282SWAN-GANZ VIPEdwards Lifesciences LLCDYG2026-03-16
00690103218602SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
00690103218626SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
00690103000382SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
50690103218287SWAN-GANZ VIPEdwards Lifesciences LLCDYG2026-03-16
50690103218638SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
00690103217094Swan-GanzEdwards Lifesciences LLCDYG2025-07-11
00690103219371SWAN GANZEdwards Lifesciences LLCDYG2024-08-30
00690103219289SWAN GANZEdwards Lifesciences LLCDYG2024-08-30
00690103219388SWAN-GANZEdwards Lifesciences LLCDYG2024-08-05
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10801902206432ARROWTELEFLEX INCORPORATEDDYG2022-10-20
10801902206456ARROWTELEFLEX INCORPORATEDDYG2022-10-20
20801902206330ARROWTELEFLEX INCORPORATEDDYG2022-10-20
20801902206439ARROWTELEFLEX INCORPORATEDDYG2022-10-20
20801902206453ARROWTELEFLEX INCORPORATEDDYG2022-10-20
10801902209372ARROWTELEFLEX INCORPORATEDDYG2022-05-20
20801902209379ARROWTELEFLEX INCORPORATEDDYG2022-05-20
10801902208979ARROWTELEFLEX INCORPORATEDDYG2022-03-18
20801902208976ARROWTELEFLEX INCORPORATEDDYG2022-03-18
10801902206647ARROWTELEFLEX INCORPORATEDDYG2022-03-14
10801902206654ARROWTELEFLEX INCORPORATEDDYG2022-03-14
10801902206661ARROWTELEFLEX INCORPORATEDDYG2022-03-14
10801902206678ARROWTELEFLEX INCORPORATEDDYG2022-03-14
10801902206715ARROWTELEFLEX INCORPORATEDDYG2022-03-14
10801902206722ARROWTELEFLEX INCORPORATEDDYG2022-03-14
10801902206739ARROWTELEFLEX INCORPORATEDDYG2022-03-14
10801902206746ARROWTELEFLEX INCORPORATEDDYG2022-03-14
20801902206644ARROWTELEFLEX INCORPORATEDDYG2022-03-14