Dar

FDA UDI

Class I (US FDA UDI)

by Covidien LP

Identity

Trade Name: DAR FDA UDI
Generic Name: Suction system catheter, general-purpose FDA UDI
Device Name: Closed Suction System, Replaceable Catheter Tracheostomy Length;Model DETACH. DSE TRACHEOSTOMY FDA UDI
Model / Reference: 444SP02312 FDA UDI
Description: Closed Suction System, Replaceable Catheter Tracheostomy Length;Model DETACH. DSE TRACHEOSTOMY FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521822955 FDA UDI
FDA Product Code: BSY FDA UDI
GMDN Term: Suction system catheter, general-purpose FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.6810 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 365 Millimeter FDA UDI
Outer Diameter — 4.0 Millimeter FDA UDI

Category: Suction system catheter, general-purpose

Dar by Covidien LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Gen2 — SURGIX MEDICAL LLC · Class II
GP General Purpose Drainage Catheter — Uresil Corp. · Class I
Integra® Jarit® — Integra LifeSciences Production Corporation · Class II
Gen2 — SURGIX MEDICAL LLC · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Covidien LP

Sources (1)

FDA UDI e2086cc6-6d14-4373-b49f-4ecb328c86dc 36 fields · synced May 30, 2026