FDA UDI
In Commercial Distribution
🇺🇸 United States
CAIRE Inc.
DI: M766AS200410
·
Model: AS200-41
·
CAIRE INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CAIRE Inc.
- Primary DI
- M766AS200410
- Version / Model
- AS200-41
- Catalog Number
- AS200-41
- Company Name
- CAIRE INC.
- Labeler DUNS
- 807537683
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-13
- Public Version
- 1
- Public Version Date
- 2025-08-21
- Public Version Status
- New
- Public Device Record Key
- 62ddc57d-be3e-4275-94f7-6b440d1428e1
Device Description
FreeStyle Comfort Portable Oxygen Concentrator with autoSAT function and single 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
- MR Unsafe
- 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 | M766AS200410 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250671 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 41 – 104 Degrees Fahrenheit