Procure

FDA UDI

Class I (US FDA UDI)

by Twin Med, LLC

Identity

Trade Name: Procure FDA UDI
Generic Name: Tracheostomy tube neck holder, single-use FDA UDI
Device Name: Trach Tie Bariatric, w/proprietary material that pulls moisture away from patient, 2 Piece, L 28" x 1.5" FDA UDI
Model / Reference: 010-101606 FDA UDI
Description: Trach Tie Bariatric, w/proprietary material that pulls moisture away from patient, 2 Piece, L 28" x 1.5" FDA UDI

Identifiers

Catalog Number: 010-101606 FDA UDI
Primary DI / UDI-DI: 10840330700723 FDA UDI
FDA Product Code: CBH FDA UDI
GMDN Term: Tracheostomy tube neck holder, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5770 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 28 Inch FDA UDI
Width — 1.5 Inch FDA UDI

Category: Tracheostomy tube neck holder, single-use

Procure by Twin Med, LLC — 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: Twin Med, LLC

Sources (1)

FDA UDI 8d517ce5-87f3-4308-9d42-df0e06d2c514 36 fields · synced Jun 1, 2026