Smartneedle

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: SMARTNEEDLE FDA UDI
Generic Name: Noninvasive vascular ultrasound system FDA UDI
Device Name: SmartNeedle FDA UDI
Model / Reference: IPN039091 FDA UDI
Description: SmartNeedle FDA UDI

Identifiers

Catalog Number: 78030 FDA UDI
Primary DI / UDI-DI: 10841156103446 FDA UDI
FDA Product Code: ITX FDA UDI
GMDN Term: Noninvasive vascular ultrasound system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 22 Gauge FDA UDI

Category: Noninvasive vascular ultrasound system

Smartneedle by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Noninvasive vascular ultrasound system.

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DigiDop — Newman Medical · Class II
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Vave — VAVE HEALTH INC · Class II
TRIA II Display Doppler — CooperSurgical, Inc. · Class II
Summit Doppler — CooperSurgical, Inc. · Class II
DigiDop — Newman Medical · Class II

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 II	Pending data

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Manufacturer

Manufacturer: Teleflex Incorporated

Sources (1)

FDA UDI e557163e-acc4-4243-993d-10864f149579 36 fields · synced Jun 8, 2026