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Cardinal Health

FDA UDI

Class II (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name
CARDINAL HEALTH FDA UDI
Generic Name
Cardiothoracic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
ATHENS AV FISTULA PACK FDA UDI
Model / Reference
SAN21AVAR8 FDA UDI
Description
ATHENS AV FISTULA PACK FDA UDI

Identifiers

Catalog Number
SAN21AVAR8 FDA UDI
Primary DI / UDI-DI
10195594373269 FDA UDI
FDA Product Code
OEZ FDA UDI
GMDN Term
Cardiothoracic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiothoracic surgical procedure kit, non-medicated, single-use

A comprehensive collection of sterile cardiothoracic surgical instruments, dressings, and materials for use during cardiothoracic surgery.

Similar devices

Also classified as Cardiothoracic surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinal Health 200, LLC

Sources (1)

  • FDA UDI 76cd652f-ca60-410b-b2f3-93b134b0fdeb 34 fields · synced Jul 15, 2026