Portable Therapeutic Liquid Oxygen System
Basic Information
- Brand Name
- Portable Therapeutic Liquid Oxygen System
- Primary DI
- 10815363020025
- Version / Model
- 50C-0021-1
- Catalog Number
- 50C-0021-1
- Company Name
- ESSEX INDUSTRIES, INC.
- Labeler DUNS
- 006320915
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-18
- Public Version
- 4
- Public Version Date
- 2019-10-23
- Public Version Status
- Update
- Public Device Record Key
- 55f9e4e8-d9f6-4051-943f-5af7422b4212
Device Description
The Portable Therapeutic Liquid Oxygen System (PTLOX) is a low pressure portable 10.0 liter liquid oxygen storage and gaseous delivery system, capable of supplying up to 8600 gaseous liters of oxygen at a maximum flow rate of 45 liters per minute at 50 psig. The unit features three quick disconnect outlet ports and comes with an accessory kit containing three 20 foot medical grade hoses, three flow control valves and three humidifier bottles. The three flow control valves can deliver oxygen to three patients at flow rates from .5 to 15 liters per minute. The quick disconnect outlet ports can also supply 50 psi of oxygen to other medical devices. Weighing less than 100 pounds when full, the PTLOX can be carried by two ground support personnel or mounted in an aircraft. The PTLOX requires no external power and uses just two 9-Volt batteries for the quantity indicator. The system has been tested to MIL-STD-810.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYJ | Unit, Liquid-Oxygen, Portable | Anesthesiology | 868.5655 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35910 | Portable liquid oxygen unit | An empty device designed as a portable, supplemental, refillable container intended as a storage for liquid oxygen (LOX) and its conversion into gaseous form for delivery of medical oxygen (O2) at various pulsed or fixed flow settings to a patient who typically has difficulty extracting O2 from the atmosphere. It typically consists of a cryogenic canister containing the LOX, a mechanism (e.g., a warming coil) where the LOX is converted into gas, a gas delivery control device (e.g., demand valve or fixed flow mechanism) that regulates the flow of O2 to the patient, a fill port and an outlet connection for connection of a nasal cannula or face mask. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10815363020025 | GS1 |
Customer Contacts
- Phone
- 314.832.4500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K880183 | 000 |