All Flow Resp. Disp. Mthpc.

GUDID 10384620000808

ALLIANCE TECH MEDICAL INC

Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use

• Primary Device ID: 10384620000808
• NIH Device Record Key: b98d890a-fcc5-4fd7-b7ee-491e747e7d25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: All Flow Resp. Disp. Mthpc.
• Version Model Number: 3125500
• Company DUNS: 144713174
• Company Name: ALLIANCE TECH MEDICAL INC
• Device Count: 100
• 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: 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	00384620000801 [Primary]
GS1	10384620000808 [Unit of Use]

FDA Product Code

• BYP: Mouthpiece, Breathing

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: 2023-09-18
• Device Publish Date: 2023-09-08

Devices Manufactured by ALLIANCE TECH MEDICAL INC

• 10384620000730 - InFloCone: 2023-09-18
• 10384620000754 - All Flow Valved Insp. Mthpc: 2023-09-18
• 10384620000761 - All Flow Valved Ex.Mthpc.: 2023-09-18
• 10384620000778 - All Flow Adult Disp Mthpc.: 2023-09-18
• 10384620000785 - All Flow Peds Disp Mthpc.: 2023-09-18
• 10384620000792 - All Flow Mthpc. Adapter: 2023-09-18
• 10384620000808 - All Flow Resp. Disp. Mthpc.: 2023-09-18
• 10384620000808 - All Flow Resp. Disp. Mthpc.: 2023-09-18
• 10384620000815 - All Flow Thermoplastic Rbr Mthpc.: 2023-09-18