Intubation Shield 20-P01-00-0000

GUDID 00857387006565

Intubation Shield

PARAGON MEDICAL, INC.

Face splash shield, reusable

• Primary Device ID: 00857387006565
• NIH Device Record Key: 29536b00-6ef5-4670-bdb9-478be295463f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intubation Shield
• Version Model Number: 20-P01-00-0000
• Catalog Number: 20-P01-00-0000
• Company DUNS: 609244454
• Company Name: PARAGON MEDICAL, INC.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-225-6975
• Email: info@paragonmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857387006565 [Primary]

FDA Product Code

• LYU: Accessory, Surgical Apparel

Sterilization

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

[00857387006565]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-22
• Device Publish Date: 2020-04-14

Devices Manufactured by PARAGON MEDICAL, INC.

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• 00857387006985 - Stryker Universal Select Sterilization Tray System: 2023-07-07 TMJ Concepts Trocar Tray
• 00857387006992 - Stryker Universal Select Sterilization Tray System: 2023-07-07 2.0 TMJ Concepts Screws Module – Set
• 00857387006565 - Intubation Shield: 2020-04-22Intubation Shield
• 00857387006565 - Intubation Shield: 2020-04-22 Intubation Shield
• 00857387006497 - Sonopet iQ Sterilization Tray: 2019-08-09 Sonopet iQ Sterilization Tray
• 00857387006428 - ChestShield Sterilization Tray System: 2019-08-09 SternalPlate Instrument Tray 1
• 00857387006435 - ChestShield Sterilization Tray System: 2019-08-09 SternalPlate Instrument Tray 2
• 00857387006442 - ChestShield Sterilization Tray System: 2019-08-09 VariSpeed Tray