FDA UDI
In Commercial Distribution
🇺🇸 United States
Proteus Digital Health Feedback System
DI: 00856602005130
·
Model: SPC-2005
·
PROTEUS DIGITAL HEALTH, INC.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Proteus Digital Health Feedback System
- Primary DI
- 00856602005130
- Version / Model
- SPC-2005
- Company Name
- PROTEUS DIGITAL HEALTH, INC.
- Labeler DUNS
- 149825791
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-02
- Public Version
- 1
- Public Version Date
- 2018-08-02
- Public Version Status
- New
- Public Device Record Key
- 7400f3e3-ecd2-4420-bd3e-856b023e689f
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OZW | Ingestible event marker | General Hospital | 880.6305 | 2 |
| DXH | TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE | Cardiovascular | 870.2920 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62237 | Medication adherence telemetric monitoring system, post-ingestion | An assembly of electronic devices intended to help assess the medication adherence of a patient who is self-managing oral medication by monitoring medication ingestion. It consists of a transmitter(s) intended to be swallowed by the patient with their medication, a patient worn transceiver with an electrode, and dedicated software. The transmitter activates upon wetting in the stomach, and transmits an electrical signal to the patient-worn transceiver, which records an event to confirm medication has been taken. The transceiver wirelessly communicates with an off-the-shelf device with the software installed, and may also record additional relevant data (e.g., heart rate, body angle). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10856602005137 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 00856602005130 | GS1 | ||||
| Package | 20856602005134 | GS1 | 6 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150494 | 000 |