Aero-Med QUE710A

GUDID 50810010894804

Fine Needle Aspiration Kit

AERO-MED, LLC

General tissue specimen container IVD, fixative/saline

• Primary Device ID: 50810010894804
• NIH Device Record Key: 42f020c9-a4c1-4392-8e30-0fc9f8a3fd58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aero-Med
• Version Model Number: QUE710A
• Catalog Number: QUE710A
• Company DUNS: 194550042
• Company Name: AERO-MED, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810010894809 [Primary]
GS1	50810010894804 [Package]; Contains: 00810010894809; Package: CASE [10 Units]; In Commercial Distribution

FDA Product Code

• NNK: CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE

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: 2025-06-10
• Device Publish Date: 2025-06-02

On-Brand Devices [Aero-Med]

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• 50885380177000: Blood Culture Kit, Ped Peripheral, University of Kansas Only
• 50885380176997: Blood Culture Kit, Adult Central Line, University of Kansas Only
• 50885380176980: Adult Blood Culture Kit, University of Kansas Hospital Only
• 50885380175907: Urine Collection Toxicology Kit, Hennepin Healthcare Only
• 50885380174184: Urine Foley Collection Kit, Baptist Health System Only
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• 50885380169838: Blood Culture Collection Kit, Pediatric, Tallahassee Memorial Hospital Only
• 50885380169821: Blood Culture Collection Kit, Tallahassee Memorial Hospital Only
• 50885380141469: Offsite - Venous Blood Collection Kit
• 50885380140189: BLOOD CULTURE KIT -Pediatric
• 50885380140172: BLOOD CULTURE KIT - Adult
• 50810010891001: Cytology Brushes
• 50810010890509: ThinPrep Collection Tools; Combo
• 50810010890493: ThinPrep Collection Tools; Broom
• 50810010890479: SurePath Collection Tools; Combo
• 50810010890462: SurePath Collection Tools; Broom
• 00810010892836: Convenience Packaging Kit
• 50810010894804: Fine Needle Aspiration Kit