FDA UDI
In Commercial Distribution
🇺🇸 United States
Care Touch
DI: 00370393904019
·
Model: CTCSW
·
FUTURE DIAGNOSTICS LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Care Touch
- Primary DI
- 00370393904019
- Version / Model
- CTCSW
- Company Name
- FUTURE DIAGNOSTICS LLC
- Labeler DUNS
- 080113296
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-27
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 86e3fd62-f3e2-4586-bb6b-7da4fdb8be73
Device Description
Digital Wrist Blood Pressure Monitor
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36551 | Patient monitoring system module, blood pressure, noninvasive | A small unit dedicated to the measurement of noninvasive blood pressure (indirect method) obtained through a standard sphygmomanometer cuff placed on the arm or leg. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the blood pressure parameter/information measured and provided by this module. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00370393904019 | GS1 | ||||
| Package | 10370393904016 | GS1 | 40 | In Commercial Distribution |
Customer Contacts
- Phone
- 646-773-5813
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131463 | 000 |