ANALGESIA GAS MIXER, MDM DELIVERY SYSTEM

GUDID 00816711020271

INTL MDM ASSEMBLY, AUSTRALIA, 30% MIN

PARKER-HANNIFIN CORPORATION

Inhalational analgesia unit

• Primary Device ID: 00816711020271
• NIH Device Record Key: bfb5336c-ceb3-4ac0-b88f-f97e5ad82882
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANALGESIA GAS MIXER, MDM DELIVERY SYSTEM
• Version Model Number: 94500323
• Company DUNS: 004175550
• Company Name: PARKER-HANNIFIN CORPORATION
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• 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	00816711020271 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945722

FDA Product Code

• BSZ: Gas-Machine, Anesthesia

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [ANALGESIA GAS MIXER, MDM DELIVERY SYSTEM]

• 00816711020271: INTL MDM ASSEMBLY, AUSTRALIA, 30% MIN
• 00816711020264: MDM ASSEMBLY, INTERNATIONAL STANARD ISO
• 00816711020240: FLOWMETER ASSY,MDM
• 00816711020233: INTL MDM ASSY-SWEDISH, 40% MIN
• 00816711020226: INTL MDM ASSY-FRANCE, 50% MIN O2
• 00816711020219: FLOWMETER ASSY,MDM-CAN.