FDA UDI
In Commercial Distribution
🇺🇸 United States
1 BY ONE
DI: 00858069007153
·
Model: 9-JK14US06
·
1BYONEPRODUCTS INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- 1 BY ONE
- Primary DI
- 00858069007153
- Version / Model
- 9-JK14US06
- Company Name
- 1BYONEPRODUCTS INC.
- Labeler DUNS
- 845019202
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-08
- Public Version
- 1
- Public Version Date
- 2020-06-16
- Public Version Status
- New
- Public Device Record Key
- f38ba816-c093-4b4d-a6ef-684898ff0dcd
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 45618 | Telemetric sphygmomanometer | An electrically-powered device designed to noninvasively measure blood pressure by automatically inflating and deflating a cuff that typically fits around a limb (arm or thigh); it may in addition measure the heart rate and mean arterial pressure. It typically incorporates a display and controls, and may include a blood pressure cuff with connection tubing. The measurements can be wirelessly sent to a medical facility for analysis, typically using a computer or mobile phone with a dedicated software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00858069007177 | GS1 | gift box | 1 | In Commercial Distribution | |
| Primary | 00858069007153 | GS1 | ||||
| Package | 10858069007174 | GS1 | carton | 18 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 45 Degrees Celsius