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Dopplex

FDA UDI

Class II (US FDA UDI)

by Huntleigh Healthcare , Ltd.

Identity

Trade Name
DOPPLEX FDA UDI
Generic Name
Noninvasive ankle brachial pressure index measurement unit FDA UDI
Device Name
STANDARD PAPER ROLL (PKD 5) FDA UDI
Model / Reference
ACC-VAS-017 FDA UDI
Description
STANDARD PAPER ROLL (PKD 5) FDA UDI

Identifiers

Catalog Number
ACC-VAS-017 FDA UDI
Primary DI / UDI-DI
05051968030429 FDA UDI
510(k) Number
K121108 FDA UDI
FDA Product Code
JOM FDA UDI
GMDN Term
Noninvasive ankle brachial pressure index measurement unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2780 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Noninvasive ankle brachial pressure index measurement unit

Dopplex by Huntleigh Healthcare , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Noninvasive ankle brachial pressure index measurement unit.

Cleared under the same submission

K121108 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Huntleigh Healthcare , Ltd.

Sources (1)

  • FDA UDI c3624508-1fd7-4535-ac34-5bb368742957 37 fields · synced May 30, 2026