FDA UDI
In Commercial Distribution
🇺🇸 United States
WAVE Clinical Platform
DI: 00856128007007
·
Model: NG
·
EXCEL MEDICAL ELECTRONICS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WAVE Clinical Platform
- Primary DI
- 00856128007007
- Version / Model
- NG
- Company Name
- EXCEL MEDICAL ELECTRONICS LLC
- Labeler DUNS
- 079605674
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-29
- Public Version
- 4
- Public Version Date
- 2018-11-08
- Public Version Status
- Update
- Public Device Record Key
- 2db7d593-7603-4978-8f06-2e598421cace
Device Description
The WAVE Clinical Platform software displays, routes, and stores medical device and diagnostic information from supported devices.
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
- 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 |
|---|---|---|---|---|
| MWI | Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57967 | Medical equipment clinical data interfacing software | An application software designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information management. It is intended to transfer waveform, infusion data, laboratory data from medical devices/lab equipment into an electronic medical record (EMR) or an application for viewing and verification by a clinician. The data can be aggregated for, e.g., patient treatment summary calculations, ordering of infusion solutions/drugs, and laboratory sample tests; it is not primarily intended to manage diagnostic/patient images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856128007007 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171056 | 000 |