Aero-Sat

GUDID 10841470109803

PULMODYNE INC

Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use

• Primary Device ID: 10841470109803
• NIH Device Record Key: 8a926478-fadd-448b-8bb6-08a2fc50934a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aero-Sat
• Version Model Number: 000102
• Company DUNS: 030619483
• Company Name: PULMODYNE 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470109806 [Primary]
GS1	10841470109803 [Package]; Contains: 00841470109806; Package: [25 Units]; In Commercial Distribution
GS1	20841470109800 [Package]; Contains: 00841470109806; Package: [500 Units]; In Commercial Distribution

FDA Product Code

• BYD: Condenser, Heat And Moisture (Artificial Nose)

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: 2020-08-04
• Device Publish Date: 2020-07-27

On-Brand Devices [Aero-Sat]

• 10841470110212: 000602
• 10841470110434: 102302
• 10841470110267: 000702
• 10841470109803: 000102