FDA UDI
In Commercial Distribution
🇺🇸 United States
MY01 Mobile Application
DI: 07540162030093
·
Model: v1.22
·
MY01 Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MY01 Mobile Application
- Primary DI
- 07540162030093
- Version / Model
- v1.22
- Catalog Number
- MY01-APP
- Company Name
- MY01 Inc
- Labeler DUNS
- 203869834
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-29
- Public Version
- 2
- Public Version Date
- 2025-07-30
- Public Version Status
- Update
- Public Device Record Key
- eb2efd20-e0d4-4793-be30-489122d5e849
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| LXC | Monitor, Pressure, Intracompartmental | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58296 | Compartmental-pressure monitoring system, single-use | An assembly of devices designed to measure and display, periodically or continuously, the interstitial pressure in a closed fascial compartment of muscle. It typically consists of a battery-powered, hand-held, pressure-measuring instrument with a display and connected devices used to access the muscle compartment (e.g., a prefilled syringe, one-way valves, and a side ported noncoring needle and/or slit catheter). It is intended to assess chronic and/or acute compartmental syndrome, a condition of increased intra-compartmental pressures from swelling within muscle compartments and tendon sheaths due to trauma. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540162030093 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242997 | 000 |