FDA.reportPublic FDA data

Edwards Reusable Rail

Primary DI
00690103219500
Brand
Edwards Reusable Rail
Company
Edwards Lifesciences LLC
Model
10500RL
Catalog number
10500RL
Device description
Edwards Reusable Rail
Published
2025-07-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00690103219500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103219500006901032195006901032195000690103219500

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac implantation catheter holder, reusableA 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 reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry place

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9637tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
DM exempt
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103205084FOGARTY120403FP120403FP2020-09-15
00690103218602SWAN-GANZ TRUE SIZE096F6096F6P2026-03-16
00690103218626SWAN-GANZ TRUE SIZE111F7111F7P2026-03-16
00690103218633SWAN-GANZ TRUE SIZE114F7114F7P2026-03-16
00690103000245SWAN-GANZ TRUE SIZE096F6096F6P2016-09-03
00690103000269SWAN-GANZ110F5110F52016-09-03
00690103000276SWAN-GANZ TRUE SIZE111F7111F7P2016-09-03
00690103000313SWAN-GANZ TRUE SIZE114F7114F7P2016-09-03
00690103220223TRIFORMIS RESILIA Tricuspid Valve11300T2511300T252026-05-28
00690103220230TRIFORMIS RESILIA Tricuspid Valve11300T2711300T272026-05-28
00690103220247TRIFORMIS RESILIA Tricuspid Valve11300T2911300T292026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid Valve11300T3111300T312026-05-28
00690103220261TRIFORMIS RESILIA Tricuspid Valve11300T3311300T332026-05-28
00690103019643HEART VALVE ACCESSORY1170117019MM2026-04-06
00690103019650HEART VALVE ACCESSORY1170117021MM2026-04-06
00690103019674HEART VALVE ACCESSORY1170117025MM2026-04-06
00690103019698HEART VALVE ACCESSORY1170117029MM2026-04-06
00690103019704HEART VALVE ACCESSORY1174M1174M242026-04-06
00690103019711HEART VALVE ACCESSORY1174M1174M262026-04-06
00690103019728HEART VALVE ACCESSORY1174M1174M282026-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859244007081CouplerEBR Systems, Inc.QWA2026-07-08
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
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