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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
Angiography kit FDA UDI
Device Name
STERILE IR ANGIO PACK FDA UDI
Model / Reference
SAN32IAMES FDA UDI
Description
STERILE IR ANGIO PACK FDA UDI

Identifiers

Catalog Number
SAN32IAMES FDA UDI
Primary DI / UDI-DI
00885425129174 FDA UDI
FDA Product Code
OEQ FDA UDI
GMDN Term
Angiography kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1650 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: Angiography kit

Cardinal Health's STERILE IR ANGIO PACK is a comprehensive angiography kit designed for the safe and effective use of contrast media in cardiovascular procedures. This single-use device features a sterile, implantable design with a unique packing system that ensures optimal sterility and convenience. With its reliable performance and durable construction, this kit is ideal for routine applications.

Similar devices

Also classified as Angiography kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 41cb429c-37d9-44c4-b67a-fdea4dd2ff1f 34 fields · synced Jul 21, 2026