FDA UDI
In Commercial Distribution
🇺🇸 United States
O2-MAX
DI: 00841470100148
·
Model: 313-8201-6
·
PULMODYNE INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- O2-MAX
- Primary DI
- 00841470100148
- Version / Model
- 313-8201-6
- Company Name
- PULMODYNE INC
- Labeler DUNS
- 030619483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-12
- Public Version
- 1
- Public Version Date
- 2025-04-21
- Public Version Status
- New
- Public Device Record Key
- 7bcb70d9-5f93-480b-bc47-8b4641305428
Device Characteristics
- Single Use
- Yes
- 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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | Anesthesiology | 868.5965 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64810 | In-line CPAP gas flow management unit, adjustable | A portable non-electronic device intended to mix ambient air with compressed oxygen (O2) to generate a flow of oxygen rich air to a patient with adjustable inspired oxygen concentration (FiO2) [e.g., 28-100%] and adjustable flow rate, for continuous positive airway pressure (CPAP) with oxygen, during noninvasive and invasive ventilation (i.e., capable of both). Also known as a CPAP flow generator, it includes an oxygen supply connection, ambient air inlet, patient outlet, and controls for adjustment of both flow rate and FiO2. CPAP pressure is defined by the PEEP valve used with this device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10841470100145 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00841470100148 | GS1 |