FDA.report

BRK-™1

Primary DI
05414734207232
Brand
BRK-™1
Company
ST. JUDE MEDICAL, INC.
Model
XS Series
Catalog number
G407216
Device description
Transseptal Needle
Published
2015-11-13
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
DRCTrocar

Product Code Classifications

CodeDeviceSpecialtyClass
DRCTrocarCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05414734207232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05414734207232054147342072325414734207232

GMDN Terms

TermDefinition
Cardiac transseptal needleA device designed to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access typically to facilitate fluid aspiration and injection/infusion, blood sampling, and pressure monitoring. It is typically a long, thin stainless steel tube that is curved and pointed at the distal end, usually having a hub with a stopcock and orientation indicators at the proximal end. It may include a stylet for support during handling. This is a single-use device.

Device Sizes

TypeValueUnit
Length89Centimeter
Outer Diameter1.3Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Keep away from sunlight. Protect from heat and radioactive source
Special Storage Condition, Specify00Store in a cool, dark, dry place.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags

DUNS number
149818952
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
true
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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