FDA.report

NA

Primary DI
04046964325823
Brand
NA
Company
B. BRAUN MEDICAL INC.
Model
601296
Catalog number
601296
Device description
CORONARY SINUS BALLOON VENOGRAPHY CATH
Published
2016-09-23
Public version status
Update
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
DYGCATHETER, FLOW DIRECTED

Product Code Classifications

CodeDeviceSpecialtyClass
DYGCatheter, Flow DirectedCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964325823PrimaryGS10
04046964325809Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964325823040469643258234046964325823
04046964325809040469643258094046964325809

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00AVOID PROLONGED EXPOSURE
Special Storage Condition, Specify00TO DIRECT LIGHT
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

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

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