AMSure® Suction Catheter Tray

FDA UDI

Class I (US FDA UDI)

by Amsino International, Inc.

Identity

Trade Name: AMSure® Suction Catheter Tray FDA UDI
Generic Name: Secretion suction kit FDA UDI
Device Name: AMSure® Suction Catheter Tray SIZE:12Fr. CONTENTS: 1 each Catheter 1 pair of Yellow Colored Vinyl Gloves 1 bottle Sterile 0.9% Saline Solution, 100mL FDA UDI
Model / Reference: 1 FDA UDI
Description: AMSure® Suction Catheter Tray SIZE:12Fr. CONTENTS: 1 each Catheter 1 pair of Yellow Colored Vinyl Gloves 1 bottle Sterile 0.9% Saline Solution, 100mL FDA UDI

Identifiers

Catalog Number: AS394C FDA UDI
Primary DI / UDI-DI: 10704411008781 FDA UDI
FDA Product Code: BSY 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

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

Category: Secretion suction kit

AMSure® Suction Catheter Tray by Amsino International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Amsino International, Inc.

Sources (1)

FDA UDI a2b18879-cd34-4801-89e1-61987e912636 34 fields · synced May 30, 2026