FDA UDI
In Commercial Distribution
🇺🇸 United States
Onera STS
DI: 08720256698043
·
Model: 01.00
·
Onera B.V.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Onera STS
- Primary DI
- 08720256698043
- Version / Model
- 01.00
- Catalog Number
- ONERA STS1 CHEST/LEG CRADLE
- Company Name
- Onera B.V.
- Labeler DUNS
- 492293557
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-15
- Public Version
- 1
- Public Version Date
- 2023-03-23
- Public Version Status
- New
- Public Device Record Key
- 43a9cc5d-d573-4623-a929-9c4164e16715
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
- 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 |
|---|---|---|---|---|
| MNR | Ventilatory Effort Recorder | Anesthesiology | 868.2375 | 2 |
| OLV | Standard Polysomnograph With Electroencephalograph | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47567 | Polysomnography analyser | A mains electricity (AC-powered) device designed to record and interpret a variety of physiologic functions during sleep to evaluate sleep/sleep-related disorders (e.g., insomnia, hypersomnia, apnoea). It typically performs electroencephalography, electrocardiography, electro-oculography, electromyography, and respiration, temperature, and pulse oximetry readings. It may also provide audiovisual information about the sleeping patient for behavioral analysis and other measurements (e.g., gastric reflux, bedwetting). The device includes electrodes, measuring instruments, samplers, filters, amplifiers, and appropriate software for processing data and providing patient diagnoses. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08720256698043 | GS1 |
Customer Contacts
- Phone
- +31403082177
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210593 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 259 | Gram | |
| Length | 160 | Millimeter | |
| Width | 50 | Millimeter | |
| Height | 86 | Millimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius