galemed Sil.Flex Stoma Pad #2

GUDID 64710810116461

GALEMED CORPORATION

Laryngectomy tube, sterile

• Primary Device ID: 64710810116461
• NIH Device Record Key: 1cbb7fd2-e418-48c9-b9d0-2091cec842b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: galemed
• Version Model Number: SP02
• Catalog Number: Sil.Flex Stoma Pad #2
• Company DUNS: 656854379
• Company Name: GALEMED CORPORATION
• Device Count: 10
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	24710810116463 [Primary]
GS1	64710810116461 [Package]; Contains: 24710810116463; Package: Carton [16 Units]; In Commercial Distribution
GS1	94710810116462 [Unit of Use]

FDA Product Code

• CBH: Device, Fixation, Tracheal Tube

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-15

On-Brand Devices [galemed]

• 44710810117129: 3431
• 44710810087392: 38023
• 44710810111240: 3426
• 64710810116966: SP01
• 64710810116461: SP02
• 64710810115990: SP03
• 44710810089440: 8581G