OTOMED, INC.

GUDID 00850038863081

OTOMED® SUCTION TUBING

Directmed, Inc.

Surgical irrigation tubing set, single-use

• Primary Device ID: 00850038863081
• NIH Device Record Key: fcaea6e1-a3a6-44d4-90c9-2c8847a242c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTOMED, INC.
• Version Model Number: SP-4000
• Company DUNS: 969484237
• Company Name: Directmed, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850038863081 [Primary]

FDA Product Code

• GBX: Catheter, Irrigation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-08
• Device Publish Date: 2023-10-31

On-Brand Devices [OTOMED, INC.]

• 10850038863088: OTOMED® SUCTION TUBING
• 10850038863071: LEVINE IRRIGATION – SUCTION TUBING
• 00850038863081: OTOMED® SUCTION TUBING
• 00850038863074: LEVINE IRRIGATION – SUCTION TUBING