FDA UDI In Commercial Distribution 🇺🇸 United States

EPIQ 5 Diagnostic Ultrasound System

DI: 00884838047686 · Model: 989605408541 · Philips Ultrasound, Inc.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
EPIQ 5 Diagnostic Ultrasound System
Primary DI
00884838047686
Version / Model
989605408541
Company Name
Philips Ultrasound, Inc.
Labeler DUNS
063377717
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-03-31
Public Version
6
Public Version Date
2021-11-09
Public Version Status
Update
Public Device Record Key
de3fd13d-d861-41d3-a954-4471b19f57a4

Device Description

EPIQ 5 Diagnostic Ultrasound System

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IYO System, imaging, pulsed echo, ultrasonic
ITX Transducer, ultrasonic, diagnostic
IYN System, imaging, pulsed doppler, ultrasonic

GMDN Terms

Code Name
40761 General-purpose ultrasound imaging system

Identifiers

Type ID
Primary 00884838047686