FDA UDI In Commercial Distribution 🇺🇸 United States

Meridian M110 Fetal Monitoring System

DI: 00867696000307 · Model: M110 · MINDCHILD MEDICAL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Meridian M110 Fetal Monitoring System
Primary DI
00867696000307
Version / Model
M110
Company Name
MINDCHILD MEDICAL
Labeler DUNS
020091217
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-06-06
Public Version
3
Public Version Date
2022-11-28
Public Version Status
Update
Public Device Record Key
6fafefae-b3b4-492d-915a-da7177abc697

Device Description

The MERIDIAN M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA). The MERIDIAN M110 Fetal Monitoring System acquires and displays the FHR and UA from abdominal surface electrodes that detect the fetal ECG signals, maternal ECG signals, and of uterine muscle contraction signals.

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
MR Unsafe
Direct Marking Exempt
No
PM Exempt
Yes
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
HGM System, Monitoring, Perinatal

GMDN Terms

Code Name
37796 Foetal/maternal prenatal monitor

Identifiers

Type ID
Package 00867696000314
Primary 00867696000307