Identity
- Trade Name
- McKesson FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system FDA UDI
- Device Name
- DOPPLER KIT, ABI W/PRINTER FDA UDI
- Model / Reference
- 1153 FDA UDI
- Description
- DOPPLER KIT, ABI W/PRINTER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 40612479199666 FDA UDI
- 510(k) Number
- K093393 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
Yes
FDA UDI
Category: Noninvasive vascular ultrasound system
McKesson by Mckesson Medical-Surgical Inc. — 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
- DigiDop — Newman Medical · 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
- DigiDop — Newman Medical · Class II
Cleared under the same submission
K093393 also covers:
- LifeDop® 250 ABI system with 2 cuffs, aneroid and printer — CooperSurgical, Inc.
- MediChoice — CooperSurgical, Inc.
- MediChoice — CooperSurgical, Inc.
- Summit Doppler — CooperSurgical, Inc.
- Summit Doppler — CooperSurgical, Inc.
- Summit Doppler — CooperSurgical, Inc.
- Summit Doppler — CooperSurgical, Inc.
- Summit Doppler — CooperSurgical, Inc.
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
- Mckesson Medical-Surgical Inc.
Sources (1)
- FDA UDI 2e98f8bc-7e0e-4ba2-8868-5533103d39b6 34 fields · synced May 30, 2026