FDA UDI
In Commercial Distribution
🇺🇸 United States
Alimetry
DI: 09421906857009
·
Model: AL001-A
·
ALIMETRY LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alimetry
- Primary DI
- 09421906857009
- Version / Model
- AL001-A
- Company Name
- ALIMETRY LIMITED
- Labeler DUNS
- 671514287
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-23
- Public Version
- 4
- Public Version Date
- 2023-09-11
- Public Version Status
- Update
- Public Device Record Key
- 2683160d-4830-471c-a319-03502cefff2e
Device Description
Alimetry Reader
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| MYE | System, Electrogastrography (Egg) | Gastroenterology, Urology | 876.1735 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64488 | Myoelectric gastrointestinal motility analysis system | An assembly of devices designed to non-invasively measure gastric myoelectrical activity to assist in the diagnosis and evaluation of gastrointestinal motility disorders (e.g., tachygastria, bradygastria, functional outlet obstruction). The assembly includes an electrically-powered control unit with attached noninvasive skin myoelectric sensor(s), connected to a computing device for analysis and display. Otherwise known as an electrogastrogram, it is typically intended as an alternative to invasive manometry. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09421906857009 | GS1 |
Customer Contacts
- Phone
- +0016514477228
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 35 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity