FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00840682104227
·
Model: TOCO TRANSDUCER WATERTIGHT LOOP
·
WIPRO GE HEALTHCARE PRIVATE LIMITED
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 00840682104227
- Version / Model
- TOCO TRANSDUCER WATERTIGHT LOOP
- Company Name
- WIPRO GE HEALTHCARE PRIVATE LIMITED
- Labeler DUNS
- 650140403
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-24
- Public Version
- 6
- Public Version Date
- 2026-01-30
- Public Version Status
- Update
- Public Device Record Key
- d40c411c-d327-4c32-845b-992fc910dd02
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- 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 |
|---|---|---|---|---|
| HFM | MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC) | Obstetrics/Gynecology | 884.2720 | 2 |
| HEL | MONITOR, HEART RATE, FETAL, ULTRASONIC | Obstetrics/Gynecology | 884.2660 | 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 | 00840682104227 | GS1 |
Customer Contacts
- Phone
- +1(414)355-5000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K982651 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal