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

• 08401173133472 - Resp-O2 Endotracheal Tube Introducer (Bougie), Pediatric, 10 FR: 2024-09-26
• 08401173134226 - Resp-O2 Intubating Stylette, 12 FR: 2024-09-26 Sterile-Eo
• 00840117326002 - RespO2 Pediatric Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Bag Oxygen: 2024-09-20 Tubing, Peep Valve
• 00840117334342 - Resp-O2 Oxygen Tubing 5.4mm Step Down Adaptor: 2024-09-04
• 08401173315564 - DynaSafety Sheer Plastic Adhesive Bandages,Sterile with Non-Stick Pad: 2024-08-06 2" x 3"
• 08401173315700 - DynaSafety Sheer Plastic Adhesive Bandages,Sterile with Non-Stick Pad: 2024-08-06 2" x 3"
• 08401173284570 - DynaCare Tampons Regular Cardboard Applicator: 2024-08-02 Not-Sterile
• 00840117338067 - Resp-O2 M24 Oxygen E-Cylinder 4.6 L with CGA870 Toggle Valve: 2024-08-02