FDA UDI
In Commercial Distribution
🇺🇸 United States
EPIFLO® oxygen delivery cannula
DI: 00855526003024
·
Model: 01-110-100002
·
Ogenix
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EPIFLO® oxygen delivery cannula
- Primary DI
- 00855526003024
- Version / Model
- 01-110-100002
- Company Name
- Ogenix
- Labeler DUNS
- 829285464
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-07
- Public Version
- 4
- Public Version Date
- 2023-06-09
- Public Version Status
- Update
- Public Device Record Key
- 9aed04a7-a13d-4a12-aba1-6c4be777794e
Device Description
Oxygen delivery cannula for use with EPIFLO device only.
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
- Yes
- 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 |
|---|---|---|---|---|
| 59124 | Wound therapy oxygenator, single-use | 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; burns; postoperative or traumatic wounds). It is intended to concentrate oxygen (O2) from ambient air and pump it through an included sterile delivery tube intended to be secured to the wound bed, which is typically covered by an absorbent and occlusive dressing. It is intended to be used continuously over a prescribed period, being discarded and replaced along with the dressing as required. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00855526003024 | GS1 |
Customer Contacts
- Phone
- 7817026732
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120764 | 000 |