ProKids

GUDID 10852212003266

ProKids™ Child's Earloop Mask - Cook Children's Medical

PRESTIGE AMERITECH, LTD.

Surgical/medical face mask, single-use

• Primary Device ID: 10852212003266
• NIH Device Record Key: e3606d10-0137-41ee-863e-0b47eca44ab7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProKids
• Version Model Number: FM85030-CCM1
• Company DUNS: 199692794
• Company Name: PRESTIGE AMERITECH, LTD.
• Device Count: 75
• 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: true
• Lot Batch: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 18664018972
• Email: orders@prestigeam.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852212003269 [Primary]
GS1	10852212003266 [Package]; Contains: 00852212003269; Package: Case [10 Units]; In Commercial Distribution
GS1	80852212003265 [Unit of Use]

FDA Product Code

• FXX: Mask, Surgical

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: 2020-05-06
• Device Publish Date: 2016-09-26

On-Brand Devices [ProKids]

• 10852212003266: ProKids™ Child's Earloop Mask - Cook Children's Medical
• 00852212003214: Imprints™ Pediatric Mask, Crayon Print, Earloop (USA)