FDA UDI
In Commercial Distribution
🇺🇸 United States
iHealth
DI: 00850044118922
·
Model: KN-550LT
·
IHEALTH LAB INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- iHealth
- Primary DI
- 00850044118922
- Version / Model
- KN-550LT
- Company Name
- IHEALTH LAB INC.
- Labeler DUNS
- 054953337
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-22
- Public Version
- 1
- Public Version Date
- 2025-09-01
- Public Version Status
- New
- Public Device Record Key
- 9ced116e-afc1-485f-9642-06cc5642d156
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
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18107 | Noninvasive blood pressure physical simulator | An instrument designed to mimic the pressure variations acting on the cuff of noninvasive arterial blood pressure monitoring/measuring devices when placed on a patient's arm. It typically simulates blood pressure values (e.g., systolic, diastolic, mean) and abnormal states (e.g, hypertensive, hypotensive). It usually consists of an internal pump to generate the testing pressures, manometers, electronic circuitry, and a display. The device is used to test oscillometric noninvasive blood pressure monitors and electronic sphygmomanometers as a complete set including the transducer; some may also be used to test auscultatory sphygmomanometers. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850044118922 | GS1 | ||||
| Package | 10850044118929 | GS1 | 12 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251113 | 000 |