FDA UDI In Commercial Distribution 🇺🇸 United States

ACUSON X150 Diagnostic Ultrasound System

DI: 04056869002811 · Model: 10131661 · SIEMENS MEDICAL SOLUTIONS USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ACUSON X150 Diagnostic Ultrasound System
Primary DI
04056869002811
Version / Model
10131661
Company Name
SIEMENS MEDICAL SOLUTIONS USA, INC.
Labeler DUNS
804722783
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-24
Public Version
6
Public Version Date
2021-11-18
Public Version Status
Update
Public Device Record Key
044069ba-a1dc-4159-9459-0d2ce4117384

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
IYN System, imaging, pulsed doppler, ultrasonic

GMDN Terms

Code Name
40761 General-purpose ultrasound imaging system

Identifiers

Type ID
Primary 04056869002811

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K121646 000