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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HGM | System, Monitoring, Perinatal | Obstetrics/Gynecology | 884.2740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37796 | Foetal/maternal prenatal monitor | An electrically-powered device designed for continuous monitoring of foetal heart activity and maternal uterine contractions during the prenatal (commonly perinatal) period; it may monitor additional maternal parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse oximetry (SpO2)]. Also known as a cardiotocograph, uterine contractions are acquired using a tocodynamometer (pressure transducer) strapped onto the mother's abdomen, while foetal heart rate is typically measured with a dedicated ultrasound transducer. The results may be displayed via print-out or electronically; telemetry features may also be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00867696000314 | GS1 | Mixed case | 1 | In Commercial Distribution | |
| Primary | 00867696000307 | GS1 |