Puritan Bennett

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: Puritan Bennett FDA UDI
Generic Name: Ventilator breathing circuit, single-use FDA UDI
Device Name: Disposable Adult Circuit FDA UDI
Model / Reference: Y-6463 FDA UDI
Description: Disposable Adult Circuit FDA UDI

Identifiers

Primary DI / UDI-DI: 20884521706986 FDA UDI
510(k) Number: K002686 FDA UDI
FDA Product Code: CBK FDA UDI
GMDN Term: Ventilator breathing circuit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5895 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Ventilator breathing circuit, single-use

Puritan Bennett by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K002686 also covers:

Puritan Bennett — Covidien LP

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Covidien LP

Sources (1)

FDA UDI 1a7aa29b-7cae-41ad-b990-8e5288080171 35 fields · synced May 30, 2026