Identity
- Trade Name
- Penta Flow Oxygen Flow Splitter FDA UDI
- Generic Name
- Medical gas flowmeter, Thorpe tube FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 295 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00038214002732 FDA UDI
- FDA Product Code
- CAX FDA UDI
- GMDN Term
- Medical gas flowmeter, Thorpe tube FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.2340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical gas flowmeter, Thorpe tube
Penta Flow Oxygen Flow Splitter by Nidek Medical Products Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Nidek Medical Products Inc.
Sources (1)
- FDA UDI 847be38e-59d2-4f9d-bc31-0e4a4d4d1e20 34 fields · synced Jun 8, 2026