FDA UDI
In Commercial Distribution
🇺🇸 United States
LEADER
DI: 00096295143850
·
Model: 5915004
·
Cardinal Health 110, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- LEADER
- Primary DI
- 00096295143850
- Version / Model
- 5915004
- Catalog Number
- 5915004
- Company Name
- Cardinal Health 110, Inc.
- Labeler DUNS
- 063997360
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-02
- Public Version
- 1
- Public Version Date
- 2024-10-10
- Public Version Status
- New
- Public Device Record Key
- e3ee4062-5bea-4b0a-bff1-9f665408680b
Device Description
LDR Talking Blood Pressure Monitor with Wide Range Arm Cuff 1 monitor Kit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| 45617 | Automatic-inflation electronic sphygmomanometer, portable, arm/wrist | An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50096295143855 | GS1 | CASE | 12 | In Commercial Distribution | |
| Primary | 00096295143850 | GS1 |
Customer Contacts
- Phone
- +1(800)200-6313
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202757 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- High: 95 Percent (%) Relative Humidity