FDA UDI
In Commercial Distribution
🇺🇸 United States
NOVII
DI: 00195278115171
·
Model: NOVII+ POD
·
Datex-Ohmeda, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NOVII
- Primary DI
- 00195278115171
- Version / Model
- NOVII+ POD
- Company Name
- Datex-Ohmeda, Inc.
- Labeler DUNS
- 118933716
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-03
- Public Version
- 3
- Public Version Date
- 2025-05-06
- Public Version Status
- Update
- Public Device Record Key
- 9a2ce7db-91d9-438f-92fa-f4a1e51469b9
Device Description
NOVII+ POD
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00195278115171 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231964 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 40 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 5 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 40 Degrees Celsius