RIMED

GUDID 10842942002233

Mask, primaGARD80 Surgical Tie, Anti-fog Foam, Blue

priMED Medical Products Inc

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

• Primary Device ID: 10842942002233
• NIH Device Record Key: 533e0712-1a18-4515-8e9d-4315f8892b97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIMED
• Version Model Number: PG4-4021
• Company DUNS: 253287569
• Company Name: priMED Medical Products Inc
• 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: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842942002236 [Primary]
GS1	10842942002233 [Package]; Contains: 00842942002236; Package: Case [6 Units]; In Commercial Distribution
GS1	90842942902232 [Unit of Use]

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: 2025-07-22
• Device Publish Date: 2025-07-14

Devices Manufactured by priMED Medical Products Inc

• 10842942017503 - PRIMED / Caracal: 2025-12-04 PRIMED / Caracal Co-Brand Overhead AAMI 2 Isolation Gown, Thumbloop With Elastic Cuff, Yellow, Universal
• 10842942017510 - PRIMED / Caracal: 2025-12-04 PRIMED / Caracal Co-Brand Overhead AAMI 2 Isolation Gown, Thumbloop With Elastic Cuff, Yellow, XL
• 10842942017527 - PRIMED / Caracal: 2025-12-04 PRIMED / Caracal Co-Brand Overhead Film Gown, Thumbloops, Blue, Universal
• 10842942017534 - PRIMED / Caracal: 2025-12-04 PRIMED / Caracal Co-Brand Overhead Film Gown, Thumbloops, Blue, XL
• 10842942017497 - PRIMED: 2025-12-03 ASTM F2100 Level 2 Pediatric Mask | Ear Loops | Dinosaur Pattern
• 10842942017466 - PRIMED / Caracal: 2025-11-28 ASTM Level 1 Mask, Procedure Ear Loops, Blue
• 10842942017473 - PRIMED / Caracal: 2025-11-28 ASTM Level 2 Mask, Procedure Ear Loops, Blue
• 10842942017480 - PRIMED / Caracal: 2025-11-28 ASTM Level 3 Anti-fog Foam Mask, Ultra Soft Ear Loops, Indigo