FDA UDI
In Commercial Distribution
🇺🇸 United States
U400 ImpSoft Software
DI: B277292U400CD0
·
Model: 2.2.0
·
IMPEDIMED LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- U400 ImpSoft Software
- Primary DI
- B277292U400CD0
- Version / Model
- 2.2.0
- Catalog Number
- 292-U400CD
- Company Name
- IMPEDIMED LIMITED
- Labeler DUNS
- 757258843
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-13
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 23776b58-b860-4ea9-ab8c-f1454c5f8082
Device Description
Impsoft data management & analysis software
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
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| OBH | Monitor, Extracellular Fluid, Lymphedema, Extremity | Cardiovascular | 870.2770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36022 | Bioelectrical body composition analyser | An electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B277292U400CD2 | HIBCC | CD Sleeve | 1 | ||
| Package | B277292U400CD1 | HIBCC | CD Label | 1 | ||
| Primary | B277292U400CD0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080825 | 000 |