Revo Medical

GUDID 00850035252239

ASTM Level 1 Procedure Mask, Earloop, Blue

Revo Medical Products Inc

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 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: 00850035252239
• NIH Device Record Key: 8aa37a15-c21b-4bc7-82d4-4e199350f85c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revo Medical
• Version Model Number: RM1789
• Company DUNS: 118289620
• Company Name: Revo 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850035252017 [Unit of Use]
GS1	00850035252123 [Primary]
GS1	00850035252239 [Package]; Contains: 00850035252123; Package: Case [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-23
• Device Publish Date: 2021-12-15

On-Brand Devices [Revo Medical]

• 00850035252277: ASTM Level 3 Surgical Soft Mask, Surgical Ties, White
• 00850035252321: ASTM Level 3 Surgical Anti-Fog Tape Mask, Surgical Ties, Green
• 00850035252314: ASTM Level 1 Procedure Mask, Earloop, Yellow
• 00850035252284: ASTM Level 3 Procedure Soft Mask, Earloop, White
• 00850035252260: ASTM Level 3 Surgical Duckbill Mask, Surgical Ties, Green
• 00850035252253: ASTM Level 3 Surgical Anti-Fog Foam Mask, Surgical Ties, Iris
• 00850035252024: ASTM Level 3 Surgical Anti-Fog Film Mask, Surgical Ties, Green
• 00850035252239: ASTM Level 1 Procedure Mask, Earloop, Blue
• 00850035252000: ASTM Level 3 Procedure Anti-Fog Foam Mask, Earloop, Iris