FDA UDI
In Commercial Distribution
🇺🇸 United States
eQuinox Oxygen Concentrator
DI: M7664837SEQ0
·
Model: 4837-SEQ
·
CAIRE INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- eQuinox Oxygen Concentrator
- Primary DI
- M7664837SEQ0
- Version / Model
- 4837-SEQ
- Company Name
- CAIRE INC.
- Labeler DUNS
- 807537683
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-16
- Public Version
- 4
- Public Version Date
- 2020-04-20
- Public Version Status
- Update
- Public Device Record Key
- 99277626-79fb-48e6-9251-fb7eaa75e048
Device Description
Portable Oxygen Concentrator 0.5-3 LPM, Continuous and Pulse Dose Settings, Multi-language Voice Interface, 24 cell battery
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
- 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 |
|---|---|---|---|---|
| CAW | Generator, Oxygen, Portable | Anesthesiology | 868.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31321 | Mobile/portable oxygen concentrator | A mobile/portable mains electricity (AC-powered) device designed to concentrate oxygen (O2) from ambient air and deliver the concentrated O2, typically through an attached nasal cannula, to a patient requiring oxygen therapy. It processes the air through an internal filtration system, e.g., a molecular sieve (zeolite granules or membranes), having a large total surface area to separate nitrogen (N2) from the air. It typically consists of an air compressor, filters, dual chambers, a reservoir and controls. The O2 concentration is variable depending on the flow rate utilized. It is used in a home, institution, or a vehicle and typically has internal batteries for transportable use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M7664837SEQ0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120785 | 000 |