Identity
- Trade Name
- simpleABI FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system FDA UDI
- Device Name
- ABI-400CL Software, 4 port Cuff-Link with remote, 8MHz Doppler probe, PPG, 2x10cm cuffs, 2x12cm cuffs, 2x2.5cm disposable digit cuffs, roll stand, user manual, quick reference guides. FDA UDI
- Model / Reference
- ABI-400CL FDA UDI
- Description
- ABI-400CL Software, 4 port Cuff-Link with remote, 8MHz Doppler probe, PPG, 2x10cm cuffs, 2x12cm cuffs, 2x2.5cm disposable digit cuffs, roll stand, user manual, quick reference guides. FDA UDI
Identifiers
- Catalog Number
- ABI-400CL FDA UDI
- Primary DI / UDI-DI
- 00852785008630 FDA UDI
- 510(k) Number
- K110628 FDA UDI
- FDA Product Code
- JAF FDA UDI
- GMDN Term
- Noninvasive vascular ultrasound system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1540 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Noninvasive vascular ultrasound system
simpleABI by Newman Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Noninvasive vascular ultrasound system.
- Summit Doppler — CooperSurgical, Inc. · Class II
- Summit Doppler — CooperSurgical, Inc. · Class II
- NovaGuide™ Intelligent Ultrasound System — Novasignal Corporation · Class II
- Vave — VAVE HEALTH INC · Class II
- TRIA II Display Doppler — CooperSurgical, Inc. · Class II
- Summit Doppler — CooperSurgical, Inc. · Class II
- A.M.I. HAL Handle — AMI Agency for Medical Innovations GmbH · Class II
- SMARTNEEDLE — TELEFLEX INCORPORATED · Class II
Cleared under the same submission
K110628 also covers:
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
- Newman Medical
Sources (1)
- FDA UDI f16dcf1f-eff6-4aa1-8546-7a7d36730f24 37 fields · synced Jun 8, 2026