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Closed Suction

FDA UDI

Class I (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name
Closed Suction FDA UDI
Generic Name
Closed-suction breathing circuit connector/switch FDA UDI
Device Name
Deluxe CSS,Adult, 24-hours,Tracheostomy,305mm,12Fr,1-hand switch,w Wedge + Adapte,sterile,latex F FDA UDI
Model / Reference
VEN163120 FDA UDI
Description
Deluxe CSS,Adult, 24-hours,Tracheostomy,305mm,12Fr,1-hand switch,w Wedge + Adapte,sterile,latex F FDA UDI

Identifiers

Primary DI / UDI-DI
00848530095338 FDA UDI
FDA Product Code
GCY FDA UDI
GMDN Term
Closed-suction breathing circuit connector/switch FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4680 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

No

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
MRI Safety
MR Unsafe FDA UDI

Category: Closed-suction breathing circuit connector/switch

Closed Suction by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Closed-suction breathing circuit connector/switch.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SUNSET HEALTHCARE SOLUTIONS, Inc.

Sources (1)

  • FDA UDI bf74f9d3-bb18-4d5e-9649-1ac4b734228c 34 fields · synced May 30, 2026