FDA UDI
In Commercial Distribution
🇺🇸 United States
OxyGeni® Humidicant Pack
DI: 00851404004060
·
Model: 600003
·
Electrochemical Oxygen Concepts, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OxyGeni® Humidicant Pack
- Primary DI
- 00851404004060
- Version / Model
- 600003
- Company Name
- Electrochemical Oxygen Concepts, Inc.
- Labeler DUNS
- 948938092
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-24
- Public Version
- 1
- Public Version Date
- 2023-08-01
- Public Version Status
- New
- Public Device Record Key
- abe3963c-5da2-4e3b-bb45-4fa3b5f203c9
Device Description
The OxyGeni® Humidicant Pack is an optional accessory to the OxyGeni® System and is a non-sterile packet, containing an absorbent polymeric gel saturated with water, intended to help provide optimal humidity for the OxyGeni® Oxygen Generator when ambient relative humidity is low during continuous diffusion of oxygen (CDO™) therapy.
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| KPJ | Chamber, Oxygen, Topical, Extremity | General, Plastic Surgery | 878.5650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62350 | Wound therapy oxygenator humidification pack | A non-sterile packet, containing an absorbent polymeric gel saturated with water, intended to be used with an ambulatory wound therapy oxygenator to help provide optimal humidity for the oxygenator during continuous diffusion of oxygen (CDO) therapy. It is carried in close proximity to the oxygenator during operation and is used when the ambient relative humidity is low. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851404004060 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090681 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 86 Degrees Fahrenheit