FDA.reportPublic FDA data

Coupler

Primary DI
00859244007081
Brand
Coupler
Company
EBR Systems, Inc.
Model
M2050
Device description
The Coupler is an optional accessory for use with the WiSE Delivery Sheath and Electrode Catheter (WiSE Delivery System). The Coupler aids in the positioning and stabilization of the delivery system during the Electrode implantation procedure.
Published
2026-07-08
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
QWACardiovascular Delivery Catheter System Positioning And Stabilization Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWACardiovascular Delivery Catheter System Positioning And Stabilization DeviceCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859244007081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859244007081008592440070818592440070810859244007081

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac implantation catheter holder, single-useA noninvasive device designed to externally support a cardiac implant delivery catheter to secure and position the catheter during delivery of a cardiac implant. It is fixed onto a dedicated catheter platform and is typically a metallic or plastic structure with slots for fixing the catheter. It may be provided with additional supporting devices (e.g., the dedicated catheter platform and platform base). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Device should be stored in the original packaging in a dry, room temperature environment.

Contacts#

Phone, Email table
PhoneEmail
4087201906ebr.ra@ebrwise.com

Regulatory Flags#

DUNS number
151420580
Device count
1
DM exempt
false
Premarket exempt
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859244007005WiSE CRT System41002025-05-07
00859244007029WiSE CRT System31002025-05-07
00859244007067WiSE CRT System20002025-05-07
00859244007296WiSE CRT System51002025-05-07
00859244007043WiSE CRT System10002025-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067035950MitraClip™ and TriClip™ST. JUDE MEDICAL, INC.QWA2026-03-30
05415067035967MitraClip™ and TriClip™ST. JUDE MEDICAL, INC.QWA2026-03-30
05415067035974MitraClip™ and TriClip™ST. JUDE MEDICAL, INC.QWA2026-03-30
05415067046529MitraClip™ and TriClip™ST. JUDE MEDICAL, INC.QWA2026-03-30
07540162100338Globe® PlatformKardium IncQWA2025-09-15
07540162100352Globe® Catheter Cable SupportKardium IncQWA2025-09-15
07540162100345Globe® PlatformKardium IncQWA2025-09-15
07540162100369Globe® Catheter Cable SupportKardium IncQWA2025-09-15
00690103219494Edwards Reusable Rail ExtensionEdwards Lifesciences LLCQWA2025-07-09
00690103219500Edwards Reusable RailEdwards Lifesciences LLCQWA2025-07-09
00690103219579Edwards EVOQUE Stabilizer Edwards Lifesciences LLCQWA2025-07-09
00690103220001Edwards rail trayEdwards Lifesciences LLCQWA2025-07-09
00690103217278EdwardsEdwards Lifesciences LLCQWA2025-01-07
00690103217292EdwardsEdwards Lifesciences LLCQWA2025-01-07
00690103218015EdwardsEdwards Lifesciences LLCQWA2025-01-07
00690103217483EVOQUEEdwards Lifesciences LLCQWA2024-02-07
00690103217513EVOQUEEdwards Lifesciences LLCQWA2024-02-07
00690103217476EVOQUEEdwards Lifesciences LLCQWA2024-02-06
00690103217285EdwardsEdwards Lifesciences LLCQWA2023-07-10
00690103217308EdwardsEdwards Lifesciences LLCQWA2023-07-10
00690103218008EdwardsEdwards Lifesciences LLCQWA2023-07-10