TUBE-STAT®

GUDID 00643169457171

STYLET 8330400 TUBE-STAT ORO-TRACH ROHS

MEDTRONIC XOMED, INC.

Rigid intubation laryngoscope, reusable Rigid intubation laryngoscope, reusable

• Primary Device ID: 00643169457171
• NIH Device Record Key: 1c6b65ed-95a7-4d40-bdbc-ddd3444d4b2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TUBE-STAT®
• Version Model Number: 8330400
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 1
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169457171 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K843490

FDA Product Code

• BSR: STYLET, TRACHEAL TUBE

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: 2018-07-06
• Device Publish Date: 2016-05-01

On-Brand Devices [TUBE-STAT®]

• 00643169457188: STYLET 8330410 TUBE-STAT NASO-TRACH ROHS
• 00643169457171: STYLET 8330400 TUBE-STAT ORO-TRACH ROHS