Penta Flow Oxygen Flow Splitter
Basic Information
- Brand Name
- Penta Flow Oxygen Flow Splitter
- Primary DI
- 00038214002732
- Version / Model
- 295
- Company Name
- NIDEK MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 161382940
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-13
- Public Version
- 1
- Public Version Date
- 2023-12-21
- Public Version Status
- New
- Public Device Record Key
- 847be38e-59d2-4f9d-bc31-0e4a4d4d1e20
Device Description
The Penta Flow Oxygen Flow Splitter is a device intended to distribute oxygen enriched product gas from a source (preferably a Nidek Medical Oxygen Concentrator) to multiple independent outlets. It can be connected to any low-pressure oxygen source (concentrators, cylinders, centralized system, etc.) and is suitable for table top or wall mounting. This product enables clinicians and medics around the world to manage and redirect the flow from a single oxygen source to a simple flow splitter to serve up to five individuals per Penta Flow splitter. Two or more Penta Flow units can be connected together to serve even more individuals simultaneously. Each flowmeter is adjusted separately to ensure precise control with a visual indication of flow for safety and comfort.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated | Anesthesiology | 868.2340 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61365 | Medical gas flowmeter, Thorpe tube | A device intended to measure and regulate the flow of a medical gas [e.g., oxygen (O2), carbon dioxide (CO2), nitrous oxide (N2O), helium/oxygen gas mixture (heliox), medical air] during various procedures (e.g., therapeutic administration, anaesthesia, insufflation during surgery). It consists of an upright tube containing a float, which rises and falls in relation to gas flow, and a distal valve (compensated flowmeter) to control gas flow rate; some types include a pressure gauge/regulator. It will be calibrated to a specific medical gas and have a dedicated flow rate range, therefore some types may be dedicated to a specific patient group (e.g., neonate, infant, adult) or clinical use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00038214002732 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 30 – 140 Degrees Fahrenheit