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Breeze® Introducer Kit

FDA UDI

Class II (US FDA UDI)

by Medical Components Inc

Identity

Trade Name
BREEZE® INTRODUCER KIT FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Device Name
BREEZE® INTRODUCER KIT FDA UDI
Model / Reference
BINTN FDA UDI
Description
BREEZE® INTRODUCER KIT FDA UDI

Identifiers

Catalog Number
BINTN FDA UDI
Primary DI / UDI-DI
00884908139358 FDA UDI
FDA Product Code
OFL FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 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

No

FDA UDI

Category: Vascular catheter introduction set, nonimplantable

Breeze® Introducer Kit by Medical Components Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular catheter introduction set, nonimplantable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Components Inc

Sources (1)

  • FDA UDI d81396c9-a2c5-467e-a14e-b5d1c1cdf780 35 fields · synced May 31, 2026