Mindray 040-006322-00

GUDID 46923980108691

Reusable Breathing Circuit, Single Limb

GaleMed Xiamen Co., Ltd.

Ventilator breathing circuit, reusable

• Primary Device ID: 46923980108691
• NIH Device Record Key: 52988fca-14ef-46c2-91f4-a4b32bc7c759
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mindray
• Version Model Number: XMR0127
• Catalog Number: 040-006322-00
• Company DUNS: 527333326
• Company Name: GaleMed Xiamen Co., Ltd.
• 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: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06923980108693 [Primary]
GS1	46923980108691 [Package]; Contains: 06923980108693; Package: Carton [10 Units]; In Commercial Distribution

FDA Product Code

• CAI: Circuit, Breathing (W Connector, Adaptor, Y Piece)

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: 2024-07-29
• Device Publish Date: 2024-07-19

On-Brand Devices [Mindray]

• 46923980111172: Disposable respiratory circuit, Single Limb
• 46923980108691: Reusable Breathing Circuit, Single Limb
• 06923980108686: Disposable respiratory circuit, Single Limb
• 46923980115552: Silicone Breathing Bag, 2L