FDA UDI
In Commercial Distribution
🇺🇸 United States
OxyGeni® Oxygen Delivery Extension Set
DI: 00851404004114
·
Model: 620000
·
Electrochemical Oxygen Concepts, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OxyGeni® Oxygen Delivery Extension Set
- Primary DI
- 00851404004114
- Version / Model
- 620000
- 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
- 9173fc55-2d65-45f2-b44a-baa33342ae71
Device Description
The OxyGeni® Oxygen Delivery Extension Set is an optional accessory of the OxyGeni® System. It is a length of flexible tubing extension with connectors at both ends intended to connect the OxyGeni® Oxygen Generator to the proprietary Oxygen Diffusion Dressings to deliver oxygen (O2) to a wound bed during continuous diffusion of oxygen (CDO™) therapy. It may be secured to the skin using medical tape.
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| 62349 | Wound therapy oxygenator tubing | A sterile length of flexible tubing extension with connectors at both ends intended to connect an ambulatory wound therapy oxygenator to a wound therapy oxygenator dressing to deliver oxygen (O2) to a wound bed during continuous diffusion of oxygen (CDO) therapy. It may be secured to the skin using medical tape. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851404004114 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090681 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 86 Degrees Fahrenheit