SHIELDMATE SHI SM 2005X

GUDID 20817583020554

EARLOOP MASK W/EXTENDED SHIELD, BLUE 5 MIL.

ALPHA PRO TECH INC

Eye splash shield, single-use

• Primary Device ID: 20817583020554
• NIH Device Record Key: cfd2af72-45af-48ad-91c8-eaeb404c7a3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHIELDMATE
• Version Model Number: SHI SM 2005X
• Catalog Number: SHI SM 2005X
• Company DUNS: 003687733
• Company Name: ALPHA PRO TECH INC
• Device Count: 25
• 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: 520-281-0127
• Email: XX@XX.XX
• Phone: 520-281-0127
• Email: XX@XX.XX
• Phone: 520-281-0127
• Email: XX@XX.XX
• Phone: 520-281-0127
• Email: XX@XX.XX
• Phone: 520-281-0127
• Email: XX@XX.XX
• Phone: 520-281-0127
• Email: XX@XX.XX
• Phone: 520-281-0127
• Email: XX@XX.XX
• Phone: 520-281-0127
• Email: XX@XX.XX
• Phone: 520-281-0127
• Email: XX@XX.XX
• Phone: 520-281-0127
• Email: XX@XX.XX

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817583020550 [Unit of Use]
GS1	10817583020557 [Primary]
GS1	20817583020554 [Package]; Contains: 10817583020557; Package: CASE [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K882028

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: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-11-03

On-Brand Devices [SHIELDMATE]

• 00817583020543: TIE FACEMASK, W/SHIELD & MAGIC ARCH, ANTIFOG STRIP, BLUE BULK PACK 100
• 20817583020554: EARLOOP MASK W/EXTENDED SHIELD, BLUE 5 MIL.
• 20817583020530: TIE FACEMASK, W/SHIELD & MAGIC ARCH, ANTIFOG FOAM STRIP, BLUE
• 20817583020523: EARLOOP MASK, W/SHIELD & MAGIC ARCH, ANTIFOG FOAM STRIP, BLUE