FDA UDI
In Commercial Distribution
🇺🇸 United States
DOPPLEX
DI: 05051968016430
·
Model: CT1
·
HUNTLEIGH HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DOPPLEX
- Primary DI
- 05051968016430
- Version / Model
- CT1
- Catalog Number
- CT1
- Company Name
- HUNTLEIGH HEALTHCARE LIMITED
- Labeler DUNS
- 217207083
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-22
- Public Version
- 4
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- cbe4ff25-961b-40e7-9980-cad390f4c706
Device Description
BD3/BD4000 CONTRACTIONS TDR
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
- 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 |
|---|---|---|---|---|
| HGM | System, Monitoring, Perinatal | Obstetrics/Gynecology | 884.2740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37258 | Tocodynamometer probe | A pressure transducer intended to be placed on the abdomen of a labouring woman to convert uterine birthing contractions to electrical signals; the signals are typically displayed by a cardiotocograph (CTG). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05051968016430 | GS1 |
Customer Contacts
- Phone
- +4402920485885
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius