ProCure

FDA UDI

Class I (US FDA UDI)

by Twin Med, LLC

Identity

Trade Name: ProCure FDA UDI
Generic Name: Airway suction catheter FDA UDI
Device Name: Suction Catheter, 12Fr, Double Swivel Tracheostomy, 72 Hour, with 15mm x 22mm Flex Tube, MDI Adapter, Trach Wedge FDA UDI
Model / Reference: 1005596 FDA UDI
Description: Suction Catheter, 12Fr, Double Swivel Tracheostomy, 72 Hour, with 15mm x 22mm Flex Tube, MDI Adapter, Trach Wedge FDA UDI

Identifiers

Catalog Number: 1005596 FDA UDI
Primary DI / UDI-DI: 10840330703526 FDA UDI
FDA Product Code: BSY FDA UDI
GMDN Term: Airway suction catheter 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

Yes

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

Dimensions & Sizes

Size: Catheter Gauge — 12 French FDA UDI
Catheter Inner Diameter — 4 Millimeter FDA UDI
Length — 30.5 Centimeter FDA UDI

Category: Airway suction catheter

ProCure by Twin Med, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Airway suction catheter.

AirLife™ — Airlife, Inc. · Class I
Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Little Sucker Standard TP — Neotech Products LLC · Class II
Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
Novo Surgical Inc. — NOVO SURGICAL, 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: Twin Med, LLC

Sources (1)

FDA UDI 9dae1f9b-5eb7-4884-ad69-fd16d8b4be9a 36 fields · synced Jun 1, 2026