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 Pediatric/Neonatal, 1 Piece, 100% hypoallergenic, 10 per bag w/3 different colors, proprietary material pulls moistuer away from patient, L 11.5" x W .75" FDA UDI
Model / Reference: 010-301PRV FDA UDI
Description: Trach Tie Pediatric/Neonatal, 1 Piece, 100% hypoallergenic, 10 per bag w/3 different colors, proprietary material pulls moistuer away from patient, L 11.5" x W .75" FDA UDI

Identifiers

Catalog Number: 010-301PRV FDA UDI
Primary DI / UDI-DI: 10840330700747 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 — 11.5 Inch FDA UDI
Width — .75 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 05b6bef8-b7b8-4009-8e37-28965cd29c78 36 fields · synced Jun 1, 2026