← Back to catalogue

EMBOL-X Glide Access Device/Aortic Cannula with Flange

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
EMBOL-X Glide Access Device/Aortic Cannula with Flange FDA UDI
Generic Name
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return FDA UDI
Device Name
EMBOL-X GLIDE ACCESS DEVICE / AORTIC CANNULA WITH FLANGE FDA UDI
Model / Reference
EXGF24D FDA UDI
Description
EMBOL-X GLIDE ACCESS DEVICE / AORTIC CANNULA WITH FLANGE FDA UDI

Identifiers

Catalog Number
EXGF24D FDA UDI
Primary DI / UDI-DI
00690103170269 FDA UDI
510(k) Number
K102420 FDA UDI
FDA Product Code
DWF FDA UDI
GMDN Term
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4210 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

EMBOL-X Glide Access Device/Aortic Cannula with Flange by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Edwards Lifesciences LLC

Sources (1)

  • FDA UDI 89ef390a-4f65-429f-b179-a06d07721dc1 38 fields · synced Jun 8, 2026