FDA UDI
In Commercial Distribution
🇺🇸 United States
OmniPro System
DI: B62536084000
·
Model: OmniAmp PSG Module
·
Mays & Asscoiates
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- OmniPro System
- Primary DI
- B62536084000
- Version / Model
- OmniAmp PSG Module
- Catalog Number
- 360-8400
- Company Name
- Mays & Asscoiates
- Labeler DUNS
- 101772069
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-09
- Public Version
- 1
- Public Version Date
- 2019-12-17
- Public Version Status
- New
- Public Device Record Key
- 6891bc5b-7328-4f28-aeb5-15623378ea93
Device Description
The OmniAmp is an amplifier system for use in polysomnogram (PSG) studies in a hospital or diagnostic center.
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| OLV | Standard Polysomnograph With Electroencephalograph | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33843 | Polysomnograph | A mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B62536084000 | HIBCC |
Customer Contacts
- Phone
- 615-973-2027
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K050143 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 3.8 | Centimeter | |
| Width | 15.5 | Centimeter | |
| Length | 20.5 | Centimeter | |
| Weight | 675 | Gram |