Amerisource Bergen

GUDID 80368001105473

Face Mask with earloops & Visor Blue, Anti-Fog, Anti-Glare Level3

BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY

Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use

• Primary Device ID: 80368001105473
• NIH Device Record Key: 103f630a-6830-442f-93e4-0301548186b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amerisource Bergen
• Version Model Number: 10547
• Company DUNS: 985523874
• Company Name: BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
• 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: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00368001105477 [Primary]
GS1	20368001105471 [Package]; Contains: 00368001105477; Package: [4 Units]; In Commercial Distribution
GS1	80368001105473 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934969

FDA Product Code

• FXX: Mask, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-08
• Device Publish Date: 2021-02-26

On-Brand Devices [Amerisource Bergen]

• 80368001105473: Face Mask with earloops & Visor Blue, Anti-Fog, Anti-Glare Level3
• 00368001113052: Non-adherent Pads Sterile 2in X 3in
• 00368001113021: Non adherent Pads sterile 3in x 8in
• 00368001113014: Non-adherent Pads Sterile 3in x 4in
• 60368001100528: NITRILE EXAM GLOVES POWDER FREE LILAC COLOUR SIZE: LARGE
• 60368001100511: NITRILE EXAM GLOVES POWDER FREE LILAC COLOUR SIZE: MEDIUM
• 80368001100508: NITRILE EXAM GLOVES POWDER FREE LILAC COLOUR SIZE: SMALL
• 60368001114051: Disposable Underpads Premium 23inX36in ( 58.4gm X 91.4cm)