BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

ESHEATH OPTIMA INTRODUCER SET (14F)

DI: 00690103220629 · Model: 14000ES14 · Edwards Lifesciences LLC

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: ESHEATH OPTIMA INTRODUCER SET (14F)
Primary DI: 00690103220629
Version / Model: 14000ES14
Catalog Number: 14000ES14
Company Name: Edwards Lifesciences LLC
Labeler DUNS: 134139174
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2025-05-07
Public Version: 1
Public Version Date: 2025-05-15
Public Version Status: New
Public Device Record Key: 403b4fce-e066-41b3-b5fe-de8fc7e7dcdf

Device Description

eSheath Optima Introducer Set (14F)

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYB	Introducer, Catheter	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58865	Vascular catheter introduction set, nonimplantable	A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103220629	GS1

Customer Contacts

Phone: +1(800)822-9637
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K244046	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			14F Sheath Inner Diameter

Storage Conditions

Type: Special Storage Condition, Specify
Special Conditions: Store in a cool, dry place.