HYDROAIRE 4200002INST

GUDID B2844200002INST1

INSTITUTIONAL USE

AURORA MANUFACTURING, LLC

Air-fluidized bed

• Primary Device ID: B2844200002INST1
• NIH Device Record Key: 488b903f-e1d6-414e-be16-7b1455e7b957
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYDROAIRE
• Version Model Number: 3000
• Catalog Number: 4200002INST
• Company DUNS: 606232200
• Company Name: AURORA MANUFACTURING, 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B2844200002INST1 [Primary]

FDA Product Code

• INX: Bed, Air Fluidized

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: 2017-02-17

On-Brand Devices [HYDROAIRE]

• B2844200002INST1: INSTITUTIONAL USE
• B2844200002HU1: HOME USE