Dynarex L-Mesitran Soft

GUDID 00616784307831

DYNAREX CORPORATION

Medical-honey liquid barrier dressing, non-sterile

• Primary Device ID: 00616784307831
• NIH Device Record Key: 0c4e9c1e-556d-4d01-8b05-2dfaee746836
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynarex L-Mesitran Soft
• Version Model Number: 3078
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 24
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784307817 [Unit of Use]
GS1	00616784307824 [Unit of Use]
GS1	00616784307831 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150676

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2019-06-11
• Device Publish Date: 2019-06-03

Devices Manufactured by DYNAREX CORPORATION

• 00840117321915 - DMECare Solutions Ever-Soft Lumbar Support Cushion,18": 2025-09-01 Weight Capacity: 350 LB.
• 00840117321939 - DMECare Solutions Ever-Soft Lumbar Support Cushion, 20": 2025-09-01 Weight Capacity: 350 LB.
• 00840117321953 - DMECare Solutions Ever-Soft Lumbar Support Cushion, 22": 2025-09-01 Weight Capacity: 350 LB.
• 00616784470429 - IV Start Kit with Nitrile Gloves, Sterile-EO: 2025-08-27
• 00616784704111 - IV Adminstration Set, 10 mL, Non-Toxic: 2025-08-11 Sterile-EO
• 00616784704210 - IV Administration Sets, 10 mL, Non-Toxic: 2025-08-11 Sterile-EO
• 00616784704418 - IV Administration Set, 20 mL, Non-Toxic: 2025-08-11 Sterile-EO
• 00616784304113 - Dmecare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 16"x16". Weight Capacity: 300 LB.