Identity
- Trade Name
- OxyGeni® Humidicant Pack FDA UDI
- Generic Name
- Wound therapy oxygenator humidification pack FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 600003 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851404004060 FDA UDI
- 510(k) Number
- K090681 FDA UDI
- FDA Product Code
- KPJ FDA UDI
- GMDN Term
- Wound therapy oxygenator humidification pack FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wound therapy oxygenator humidification pack
OxyGeni® Humidicant Pack by Electrochemical Oxygen Concepts, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K090681 also covers:
- OxyGeni® — Electrochemical Oxygen Concepts, Inc.
- OxyGeni® Dual Port cannula — Electrochemical Oxygen Concepts, Inc.
- OxyGeni® Oxygen Delivery Extension Set — Electrochemical Oxygen Concepts, Inc.
- OxySpur® Oxygen Diffusion Dressing — Electrochemical Oxygen Concepts, Inc.
- OxySpur® Oxygen Diffusion Dressing — Electrochemical Oxygen Concepts, Inc.
- OxySpur® Oxygen Diffusion Dressing — Electrochemical Oxygen Concepts, Inc.
- OxySpur® Oxygen Diffusion Dressing — Electrochemical Oxygen Concepts, Inc.
- OxySpur® Oxygen Diffusion Dressing — Electrochemical Oxygen Concepts, Inc.
- OxySpur® lite Oxygen Diffusion Dressing — Electrochemical Oxygen Concepts, Inc.
- OxySpur® lite Oxygen Diffusion Dressings — Electrochemical Oxygen Concepts, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Electrochemical Oxygen Concepts, Inc.
Sources (1)
- FDA UDI abe3963c-5da2-4e3b-bb45-4fa3b5f203c9 35 fields · synced Jun 1, 2026