ProCure

FDA UDI

Class I (US FDA UDI)

by Twin Med, LLC

Identity

Trade Name: ProCure FDA UDI
Generic Name: Tracheostomy care kit, single-use FDA UDI
Device Name: Suction Catheter Kit 1- Pop-up Basin, 1-Disposable Vinyl Glove, Sterile 10FR FDA UDI
Model / Reference: 1006340 FDA UDI
Description: Suction Catheter Kit 1- Pop-up Basin, 1-Disposable Vinyl Glove, Sterile 10FR FDA UDI

Identifiers

Catalog Number: 1006340 FDA UDI
Primary DI / UDI-DI: 10840330704141 FDA UDI
FDA Product Code: BSY FDA UDI
GMDN Term: Tracheostomy care kit, single-use 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

FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 10 French FDA UDI
Outer Diameter — 3.3 Millimeter FDA UDI
Length — 55 Centimeter FDA UDI

Category: Tracheostomy care kit, single-use

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

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Also classified as Tracheostomy care kit, single-use.

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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: Twin Med, LLC

Sources (1)

FDA UDI c9c75bca-dcc9-4f99-a780-d8ebd5b6a06e 36 fields · synced Jun 7, 2026