ArroAir Elite

GUDID 10869937000029

ArroAir Elite Alternating Pressure Mattress Overlay system

ARROWHEAD HEALTHCARE SUPPLY, LLC

Alternating-pressure bed mattress overlay, reusable

• Primary Device ID: 10869937000029
• NIH Device Record Key: 55bce25e-bfc9-4bd8-aedb-cefe65037dae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ArroAir Elite
• Version Model Number: P-108050
• Company DUNS: 078585060
• Company Name: ARROWHEAD HEALTHCARE SUPPLY, LLC
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869937000022 [Primary]
GS1	10869937000029 [Package]; Contains: 00869937000022; Package: Case [6 Units]; In Commercial Distribution

FDA Product Code

• FNM: Mattress, Air Flotation, Alternating Pressure

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-22

Devices Manufactured by ARROWHEAD HEALTHCARE SUPPLY, LLC

• 00852685007009 - ArroAir DigiMax 8 LPM pump: 2018-03-29 ArroAir DigiMax 8 LPM pump
• 00852685007016 - ArroAir Deluxe LAL/AP Mattress w/ DigiMax Pump: 2018-03-29 ArroAir Deluxe LAL/AP Mattress w/ DigiMax Pump
• 00852685007023 - ArroAir Max Pump Only: 2018-03-29 ArroAir Max Pump Only
• 00852685007030 - ArroAir Premier LAL/AP Mattress w/ DigiMax Pump: 2018-03-29 ArroAir Premier LAL/AP Mattress w/ DigiMax Pump
• 10869937000029 - ArroAir Elite: 2018-03-29ArroAir Elite Alternating Pressure Mattress Overlay system
• 10869937000029 - ArroAir Elite: 2018-03-29 ArroAir Elite Alternating Pressure Mattress Overlay system
• 10869937000036 - ArroTemp Infrared Thermometer: 2018-03-29 ArroTemp Infrared non-contact Thermometer
• 00869937000046 - ArroAir Max & Essential: 2018-03-29 ArroAir Max & Essential LAL/AP Mattress System, 8” Air Cells Only
• 00869937000053 - ArroAir Max & Deluxe: 2018-03-29 ArroAir Max & Deluxe LAL/AP Mattress System, 5” Air Cells with 3" Foam Cells secondary support