Penta Flow Oxygen Flow Splitter

GUDID 00038214002732

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.

NIDEK MEDICAL PRODUCTS, INC.

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• Primary Device ID: 00038214002732
• NIH Device Record Key: 847be38e-59d2-4f9d-bc31-0e4a4d4d1e20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Penta Flow Oxygen Flow Splitter
• Version Model Number: 295
• Company DUNS: 161382940
• Company Name: NIDEK MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00038214002732 [Primary]

FDA Product Code

• CAX: Flowmeter, Tube, Thorpe, Back-Pressure Compensated

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-21
• Device Publish Date: 2023-12-13

Devices Manufactured by NIDEK MEDICAL PRODUCTS, INC.

• 00038214002732 - Penta Flow Oxygen Flow Splitter: 2023-12-21The 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.
• 00038214002732 - Penta Flow Oxygen Flow Splitter: 2023-12-21 The Penta Flow Oxygen Flow Splitter is a device intended to distribute oxygen enriched product gas from a source (preferably a N
• 00038214002466 - NUVO NANO: 2023-06-15 PORTABLE OXYGEN CONCENTRATOR