FDA UDI
In Commercial Distribution
🇺🇸 United States
BioSticker™
DI: 00850005949008
·
Model: BIOST01021F
·
BIOINTELLISENSE, INC.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BioSticker™
- Primary DI
- 00850005949008
- Version / Model
- BIOST01021F
- Company Name
- BIOINTELLISENSE, INC.
- Labeler DUNS
- 116984478
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-01
- Public Version
- 2
- Public Version Date
- 2020-05-20
- Public Version Status
- Update
- Public Device Record Key
- 32ff8831-9fd3-455c-8409-315a00e78e74
Device Description
The BioSticker™ System is a wearable remote monitoring system intended for continuous collection of physiological data in home and healthcare settings.
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
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Cardiovascular | 870.2910 | 2 |
| NDC | Calculator, Drug Dose | Anesthesiology | 868.1890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36367 | Electrocardiography telemetric monitoring system transmitter | A body-worn, battery-powered component of an electrocardiography telemetric monitoring system designed to continuously measure and wirelessly transmit real-time electrocardiographic (ECG) signals [and sometimes additional parameters such as heart rate, skin temperature, or haemoglobin oxygen saturation (SpO2)] to a remote receiver (e.g., central station server); it may in addition record/analyse data during a period of time for later retrieval (Holter reporting). The transmitter typically includes an antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, and may be provided with dedicated data management/communication software. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850005949008 | GS1 | ||||
| Package | 10850005949005 | GS1 | Carton | 10 | In Commercial Distribution | |
| Package | 20850005949002 | GS1 | Master carton | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- 888-908-8804
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191614 | 000 |