FDA UDI
In Commercial Distribution
🇺🇸 United States
OxySpur® Oxygen Diffusion Dressing
DI: 00851404004046
·
Model: 4" x 5" Non-Adhesive
·
Electrochemical Oxygen Concepts, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OxySpur® Oxygen Diffusion Dressing
- Primary DI
- 00851404004046
- Version / Model
- 4" x 5" Non-Adhesive
- Catalog Number
- 600013
- 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
- b1244b95-722b-4eaf-8257-a8aee2bc3ca9
Device Description
OxySpur® Oxygen Diffusion Dressings are hydrophilic dressings designed for use with the OxyGeni® System in the management of wounds. The dressings are a multi-layer construct with a highly absorbent hydrophilic foam layer directly adjacent to the wound, a highly absorbent hydrophilic foam layer with channels for oxygen distribution, and a super absorbent polymeric laminate, all of which are covered by an occlusive film.
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
- Yes
- 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 |
|---|---|---|---|---|
| 62347 | Wound therapy oxygenator, reusable | A wearable, battery-powered device designed to actively promote continuous diffusion of oxygen (CDO) in a wound to help heal various types of wounds (e.g., arterial, venous, diabetic or pressure ulcers, skin grafts, burns, postoperative or traumatic wounds). It has oxygen (O2) delivery controls with sensors and displays for flow and pressure, and concentrates O2 from ambient air and delivers it through tubing to the wound bed, typically using a wound therapy oxygenator dressing. A battery charger, carrying case, and disposable humidification pack may be included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851404004046 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090681 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 86 Degrees Fahrenheit