FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Pulse by EHE Health
DI: B553PULSE100
·
Model: v1.0
·
WELLDOC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pulse by EHE Health
- Primary DI
- B553PULSE100
- Version / Model
- v1.0
- Company Name
- WELLDOC, INC.
- Labeler DUNS
- 021217115
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-02
- Public Version
- 5
- Public Version Date
- 2023-11-03
- Public Version Status
- Update
- Public Device Record Key
- 75e75793-fae0-4214-ba9c-4abf1ec8f78a
- Distribution End Date
- 2023-04-14
Device Description
Pulse by EHE Health (“Pulse”) is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older – who have type 1 or type 2 diabetes. Pulse is intended to assist patients in managing their diabetes with guidance from their providers.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| MRZ | Accessories, Pump, Infusion | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61215 | Home pharmaceutical management support software | A software package intended to be used by patients at home, and healthcare professionals in a clinical setting, to facilitate therapeutic pharmaceutical management decisions (e.g., dosage) by providing suggested regimes for individual patients based on their physical and laboratory data. It is intended to be used on a non-medical computerized device (e.g., to be used on mobile devices at point-of-care); it is not intended to support anaesthesia administration. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B553PULSE100 | HIBCC |
Customer Contacts
- Phone
- 18886114794
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190013 | 000 |