Ambu 000251004

GUDID 46923980100589

Open Cuff Silicone Face Mask Reusable Face Mask #3

GaleMed Xiamen Co., Ltd.

Anaesthesia face mask, reusable

• Primary Device ID: 46923980100589
• NIH Device Record Key: b3e63043-7fe3-4d2a-89cc-dcd3ec2ab456
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ambu
• Version Model Number: XAM0004
• Catalog Number: 000251004
• 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: true
• 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	06923980100581 [Primary]
GS1	46923980100589 [Package]; Contains: 06923980100581; Package: case [50 Units]; In Commercial Distribution

FDA Product Code

• BSJ: Mask, Gas, Anesthetic

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: 2025-06-09
• Device Publish Date: 2025-05-30

On-Brand Devices [Ambu]

• 46923980100602: Open Cuff Silicone Face Mask Reusable Face Mask #5
• 46923980100596: Open Cuff Silicone Face Mask Reusable Face Mask #4
• 46923980100589: Open Cuff Silicone Face Mask Reusable Face Mask #3
• 46923980100572: Open Cuff Silicone Face Mask Reusable Face Mask #2
• 46923980100565: Open Cuff Silicone Face Mask Reusable Face Mask #1
• 46923980100558: Open Cuff Silicone Face Mask Reusable Face Mask #0