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Avalign

FDA UDI

Class I (US FDA UDI)

by AVALIGN TECHNOLOGIES, Inc.

Identity

Trade Name
Avalign FDA UDI
Generic Name
Subcutaneous tunneller, reusable FDA UDI
Device Name
Rumel Tourniquet, flex-neck, FDA UDI
Model / Reference
VM77-2665 FDA UDI
Description
Rumel Tourniquet, flex-neck, FDA UDI

Identifiers

Primary DI / UDI-DI
00190776055875 FDA UDI
FDA Product Code
EYR FDA UDI
GMDN Term
Subcutaneous tunneller, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.5900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Subcutaneous tunneller, reusable

Avalign by AVALIGN TECHNOLOGIES, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Subcutaneous tunneller, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
AVALIGN TECHNOLOGIES, Inc.

Sources (1)

  • FDA UDI 63fb2098-7115-48dd-aff4-12cffc763461 34 fields · synced May 30, 2026