FDA UDI
In Commercial Distribution
🇺🇸 United States
Bigfoot Unity
DI: 00850003506630
·
Model: FG-301187
·
Bigfoot Biomedical, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bigfoot Unity
- Primary DI
- 00850003506630
- Version / Model
- FG-301187
- Catalog Number
- FG-301187
- Company Name
- Bigfoot Biomedical, Inc.
- Labeler DUNS
- 079721177
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-03
- Public Version
- 1
- Public Version Date
- 2023-04-11
- Public Version Status
- New
- Public Device Record Key
- b78fa659-d92f-4d79-b8dd-a66374c31cfe
Device Description
Bigfoot Unity Pen Cap for Tresiba
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| QLG | Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems | Clinical Chemistry | 862.1355 | 2 |
| QOG | Injection Data Capture Device | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44611 | Percutaneous interstitial-fluid glucose monitoring system, electrochemical | An assembly of electrically-powered, portable devices intended to continuously monitor interstitial-fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously-inserted electrode that physically connects to a cable or transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system may be used in the home and clinical settings, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850003506630 | GS1 |
Customer Contacts
- Phone
- 888-523-3662
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202145 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -13 – 158 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity