All Flow

GUDID 00384620000061

ALLIANCE TECH MEDICAL INC

Pulmonary function testing kit

• Primary Device ID: 00384620000061
• NIH Device Record Key: d362bca8-e0b6-4c32-9357-e3a84c49d13c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: All Flow
• Version Model Number: 5558100
• Company DUNS: 144713174
• Company Name: ALLIANCE TECH MEDICAL INC
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• 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: 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	00384620000061 [Primary]
GS1	10384620000068 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043148

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-12
• Device Publish Date: 2016-09-26

On-Brand Devices [All Flow]

• 00384620000054: 5557100
• 00384620000153: 7779100
• 00384620000146: 7778100
• 00384620000139: 7777100
• 00384620000122: 7776100
• 00384620000115: 7775100
• 00384620000108: 7774100
• 00384620000092: 7773100
• 00384620000085: 7771100
• 00384620000078: 5559100
• 00384620000061: 5558100
• 00384620000047: 5556100
• 00384620000030: 5555100
• 00384620000023: 5554100
• 00384620000016: 5553100
• 00384620000009: 5551100