Sil-Flex

GUDID 04710810083198

New Sil-Flex Silicone Mask size 3, Child Large

GaleMed Xiamen Co., Ltd.

Anaesthesia face mask, reusable

• Primary Device ID: 04710810083198
• NIH Device Record Key: b686b1c3-c85f-4a9c-96a9-da5cea5ee4f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sil-Flex
• Version Model Number: 5181
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04710810083198 [Primary]
GS1	24710810083192 [Package]; Package: Box [2 Units]; In Commercial Distribution
GS1	44710810083196 [Package]; Contains: 24710810083192; Package: Carton [12 Units]; In Commercial Distribution

FDA Product Code

• BSJ: Mask, Gas, Anesthetic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-19

On-Brand Devices [Sil-Flex]

• 44710810083301: Sil-Flex tube 10F/22F，14cm
• 04710810083198: New Sil-Flex Silicone Mask size 3, Child Large