ONETRAC LXS C110320

GUDID 00850040140460

ONETRAC LXS single-use suction device with integrated cordless radial LED light source, Frazier, 12 Fr

OBP Surgical Corporation

Surgical/emergency suction cannula, illuminating, single-use Surgical/emergency suction cannula, illuminating, single-use Surgical/emergency suction cannula, illuminating, single-use Surgical/emergency suction cannula, illuminating, single-use Surgical/emergency suction cannula, illuminating, single-use Surgical/emergency suction cannula, illuminating, single-use Surgical/emergency suction cannula, illuminating, single-use Surgical/emergency suction cannula, illuminating, single-use Surgical/emergency suction cannula, illuminating, single-use Surgical/emergency suction cannula, illuminating, single-use Surgical/emergency suction cannula, illuminating, single-use Surgical/emergency suction cannula, illuminating, single-use Surgical/emergency suction cannula, illuminating, single-use Surgical/emergency suction cannula, illuminating, single-use Surgical/emergency suction cannula, illuminating, single-use Surgical/emergency suction cannula, illuminating, single-use

• Primary Device ID: 00850040140460
• NIH Device Record Key: 42bd34bd-6a38-44e9-812b-08ac5678063a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONETRAC LXS
• Version Model Number: Frazier - 12 Fr
• Catalog Number: C110320
• Company DUNS: 118262590
• Company Name: OBP Surgical Corporation
• 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

Customer Support Contacts

• Phone: 978-291-6853
• Email: info@obpsurgical.com
• Phone: 978-291-6853
• Email: info@obpsurgical.com
• Phone: 978-291-6853
• Email: info@obpsurgical.com
• Phone: 978-291-6853
• Email: info@obpsurgical.com
• Phone: 978-291-6853
• Email: info@obpsurgical.com
• Phone: 978-291-6853
• Email: info@obpsurgical.com
• Phone: 978-291-6853
• Email: info@obpsurgical.com
• Phone: 978-291-6853
• Email: info@obpsurgical.com
• Phone: 978-291-6853
• Email: info@obpsurgical.com
• Phone: 978-291-6853
• Email: info@obpsurgical.com
• Phone: 978-291-6853
• Email: info@obpsurgical.com
• Phone: 978-291-6853
• Email: info@obpsurgical.com
• Phone: 978-291-6853
• Email: info@obpsurgical.com
• Phone: 978-291-6853
• Email: info@obpsurgical.com
• Phone: 978-291-6853
• Email: info@obpsurgical.com
• Phone: 978-291-6853
• Email: info@obpsurgical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850040140460 [Primary]

FDA Product Code

• JOL: Catheter And Tip, Suction

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: 2023-07-31
• Device Publish Date: 2023-07-21

On-Brand Devices [ONETRAC LXS]

• 00850040140460: ONETRAC LXS single-use suction device with integrated cordless radial LED light source, Frazier,
• 00850040140453: ONETRAC LXS single-use suction device with integrated cordless radial LED light source, Frazier,