FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 20856602005172
·
Model: SPC-2520
·
PROTEUS DIGITAL HEALTH, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
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Basic Information
- Brand Name
- NA
- Primary DI
- 20856602005172
- Version / Model
- SPC-2520
- Company Name
- PROTEUS DIGITAL HEALTH, INC.
- Labeler DUNS
- 149825791
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2019-07-12
- Public Version
- 2
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- fd809bc0-2819-4f3d-9015-3a2cac443fd4
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
- No
- 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 |
|---|---|---|---|---|
| 62238 | Medication adherence telemetric monitoring system ingestible transmitter | A non-sterile component of a medication adherence telemetric monitoring system intended to be ingested simultaneously with medication to transmit an electrical signal across tissues to a patient worn transceiver indicating that the medication has been taken. It is typically a transmitter housed in a placebo tablet which activates upon wetting (i.e., in the stomach). It does not include any active pharmaceuticals and is not intended for measuring physiological parameters. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20856602005172 | GS1 | ||||
| Unit of Use | 00856602005178 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150494 | 000 |