Sentinel

GUDID D915MBK22

Earloop Mask - Black ASTM Level 2

Plastcare USA

Surgical/medical respirator, single-use

• Primary Device ID: D915MBK22
• NIH Device Record Key: 94d40e0c-6211-4033-a93b-5993585db085
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentinel
• Version Model Number: MBK2
• Company DUNS: 079299604
• Company Name: Plastcare USA
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D915MBK20 [Unit of Use]
HIBCC	D915MBK21 [Primary]
HIBCC	D915MBK22 [Package]; Contains: D915MBK21; Package: [10 Units]; In Commercial Distribution

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: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2019-12-12

On-Brand Devices [Sentinel]

• D915MWH22: Earloop Mask - White ASTM Level 2
• D915MPI22: Earloop Mask - Pink ASTM Level 2
• D915MBL22: Earloop Mask - Blue ASTM Level 2
• D915MBK22: Earloop Mask - Black ASTM Level 2