PRIMED

GUDID 10842942012331

PRIMASOFT160, Surgical Softbill Mask, White

priMED Medical Products Inc

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

• Primary Device ID: 10842942012331
• NIH Device Record Key: 5c00e015-18ef-4b40-b86b-1aec54071e2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIMED
• Version Model Number: PG4-3443
• 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842942012334 [Primary]
GS1	10842942012331 [Package]; Contains: 00842942012334; Package: Case [6 Units]; In Commercial Distribution
GS1	90842942012337 [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

On-Brand Devices [PRIMED]

• 10842942017398: 'ASTM Level 3 Mask | Procedure Ear Loops | Blue
• 10842942017312: ASTM Level 2 Anti-Fog Strip Mask, Ultra Soft Ear Loops, Blue
• 10842942017305: ASTM Level 2 Mask | Hypoallergenic | Ultra Soft Ear Loops | Blue
• 10842942017299: ASTM Level 2 Mask | Hypoallergenic | Anti-Fog Foam | Ultra Soft Ear Loops | Blue
• 10842942017091: ASTM Level 2 Mask, Procedure Ear Loops, Blue
• 10842942017053: ASTM Level 2 Mask, Soft Mask, Anti-fog Foam, Ultra Soft Ear Loops, White
• 10842942017046: 'ASTM Level 2 Mask, Soft Mask, Ultra Soft Ear Loops, White
• 10842942017039: ASTM Level 2 Mask, Ultra Soft Ear Loops, Blue
• 10842942017022: ASTM Level 3 MRI Safe Mask, Procedure Ear Loops, Plastic Nose Piece, Green
• 10842942017008: 'ASTM Level 3 Mask, Extra long Ear loops, Indigo
• 10842942016544: ASTM Level 3 Antimicrobial Mask, Procedure Earloops, Green
• 10842942016285: ASTM Level 3 Mask, Procedure Ear Loops, Blue
• 10842942016278: ASTM Level 1 Mask, Procedure Ear Loops, Small, Blue
• 10842942016155: ASTM Level 3 Mask, Procedure Ear Loops, Small, Indigo
• 10842942016148: ASTM Level 2 Mask, Procedure Ear Loops, Small, Blue
• 10842942016063: ASTM Level 3 Pediatric Mask, Ear Loops, Indigo
• 10842942016056: ASTM Level 2 Pediatric Mask, Ear Loops, Blue
• 10842942015868: Medical Face Mask, Earloops, Anti-Fog Foam, Opal, ASTM Level 3
• 10842942015851: 'ASTM Level 3 Mask, Procedure Ear Loops, Black
• 10842942015844: ASTM Level 1 Duckbill Mask, Procedure Earloops, Blue
• 10842942015837: ASTM Level 1 Pediatric Mask, Ear Loops, Blue
• 10842942015615: ASTM Level 3 Mask, Procedure Ear Loops, Indigo
• 10842942015608: ASTM Level 2 Mask, Procedure Ear Loops, Blue
• 10842942015479: 'ASTM Level 3 Mask, Procedure Ear Loops, Violet
• 10842942015462: ASTM Level 3 Mask, Procedure Ear Loops, Black
• 10842942015417: ASTM Level 1 Mask, Procedure Ear Loops, Blue
• 10842942015288: 'Earloop Mask, Blue
• 10842942015264: Pediatric Mask, Ear Loops, Blue
• 10842942014397: ASTM Level 1 Mask, Procedure Ear Loops, Blue
• 10842942014380: ASTM Level 1 Mask, Procedure Ear Loops, Blue
• 10842942014373: ASTM Level 3 Anti-Fog Film Mask, Surgical Ties, Green
• 10842942014366: ASTM Level 3 Duckbill Mask, Surgical Ties, Large, Green
• 10842942014359: ASTM Level 3 Soft Mask, Procedure Ear Loops, White
• 10842942014311: Pediatric Mask, Ear Loops, Blue
• 10842942012393: 'Mask, primaGARD80 Procedure Ear Loop, Blue
• 10842942012386: Mask, primaGARD80 Procedure Ear Loop, Blue
• 10842942012379: Mask with visor, primaGARD160 Procedure Ear Loop, Anti-fog foam, Anti-glare, Indigo
• 10842942012362: Mask, primaGARD160 Procedure Ear Loop, Anti-fog Foam, Indigo
• 10842942012355: Mask, primaGARD80 Procedure Ear Loop, Yellow
• 10842942012348: PRIMASOFT120, Surgical Mask with Anti-Fog Foam, White
• 10842942012331: PRIMASOFT160, Surgical Softbill Mask, White
• 10842942012324: PRIMASOFT160, Surgical Mask with Visor, Anti-Fog, Anti-Glare, White
• 10842942012317: PRIMASOFT160, Surgical Mask, White
• 10842942012300: PRIMAGARD120, Surgical Mask, Blue
• 10842942012294: PRIMASOFT80, Surgical Mask with Anti-Fog Foam, White
• 10842942012287: PRIMASOFT80, Surgical Mask, White
• 10842942012270: PRIMAGARD160, Surgical Mask with Anti-Fog foam, Indigo
• 10842942012263: PRIMASOFT120, Surgical Mask, White
• 10842942012256: PRIMAGARD160, Surgical Mask with Visor Anti-Fog and Anti-Glare, Indigo
• 10842942012249: 'PRIMAGARD160, Procedure Mask, Ear Loop with anit-fog foam, Indigo