PurCel Labs ASTM Level 1 Surgical Masks

GUDID 00810143550788

ASTM Level 1 Surgical Masks, Non-Sterile, Single Use, Ear-loop, Blue, (50/Box).

Purcel Labs LLC

Surgical/medical respirator, non-antimicrobial, single-use

• Primary Device ID: 00810143550788
• NIH Device Record Key: 0937842c-4552-4adc-ab4b-1975d18c2be7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PurCel Labs ASTM Level 1 Surgical Masks
• Version Model Number: 3000-50
• Company DUNS: 127672531
• Company Name: Purcel Labs LLC
• Device Count: 50
• 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: true
• 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	00810143550771 [Primary]
GS1	00810143550788 [Package]; Contains: 00810143550771; Package: Shipping Case [50 Units]; In Commercial Distribution
GS1	10810143550778 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202708

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: 2023-08-28
• Device Publish Date: 2023-08-18

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