Suction Catheter Kit - Sterile - Includes Gloves, Catheter - 10Fr

FDA UDI

Class I (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name: Suction Catheter Kit - Sterile - Includes Gloves, Catheter - 10Fr FDA UDI
Generic Name: Secretion suction kit FDA UDI
Device Name: Suction Catheter Kit - Sterile - Includes Gloves, Catheter - 10Fr FDA UDI
Model / Reference: TRATK110 FDA UDI
Description: Suction Catheter Kit - Sterile - Includes Gloves, Catheter - 10Fr FDA UDI

Identifiers

Catalog Number: TRATK110 FDA UDI
Primary DI / UDI-DI: 00848530082079 FDA UDI
FDA Product Code: OFS FDA UDI
GMDN Term: Secretion suction kit 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

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

Yes

FDA UDI

Category: Secretion suction kit

Suction Catheter Kit - Sterile - Includes Gloves, Catheter - 10Fr by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID

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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: SUNSET HEALTHCARE SOLUTIONS, Inc.

Sources (1)

FDA UDI 0dfb3952-d1df-43de-a64f-a3c86c78d7ee 34 fields · synced May 30, 2026