OTOMED® SUCTION TUBING

GUDID 00850000126121

OTOMED® SUCTION TUBING

Oto-Med, Inc.

Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use

• Primary Device ID: 00850000126121
• NIH Device Record Key: 53bb1465-026b-4eac-8a88-d5806ab4594e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTOMED® SUCTION TUBING
• Version Model Number: SP-4000
• Company DUNS: 059817742
• Company Name: Oto-Med, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Customer Support Contacts

• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850000126121 [Primary]
GS1	10850000126128 [Package]; Package: [6 Units]; In Commercial Distribution

FDA Product Code

• GBX: Catheter, Irrigation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-07
• Device Publish Date: 2018-09-21

Devices Manufactured by Oto-Med, Inc.

• 10850000126166 - CI UNIVERSAL DRAPE: 2021-11-29 CI UNIVERSAL DRAPE
• 10850000126159 - LEVINE IRRIGATION-SUCTION TUBING: 2021-02-08 LEVINE IRRIGATION-SUCTION TUBING
• 10850000126135 - EAR DRESSING, ADULT: 2020-12-08 EAR DRESSING, ADULT
• 10850000126142 - EAR DRESSING, PEDIATRIC: 2020-12-08 EAR DRESSING, PEDIATRIC
• 00850000126015 - GLASSCOCK® EAR DRESSING, ADULT: 2020-03-13 GLASSCOCK® EAR DRESSING, ADULT
• 00850000126022 - GLASSCOCK® EAR DRESSING, PEDIATRIC: 2020-03-13 GLASSCOCK® EAR DRESSING, PEDIATRIC
• 00850000126039 - HEAD & NECK PRESSURE DRESSING: 2020-03-13 HEAD & NECK PRESSURE DRESSING
• 00850000126121 - OTOMED® SUCTION TUBING: 2019-10-07OTOMED® SUCTION TUBING
• 00850000126121 - OTOMED® SUCTION TUBING: 2019-10-07 OTOMED® SUCTION TUBING