Lithotomy AirShuttle™ RT-5100-05

GUDID 10841962111277

Lithotomy AirShuttle™

Qfix

Patient lifting system stretcher

• Primary Device ID: 10841962111277
• NIH Device Record Key: d43ab054-df0c-4b43-bea1-6d43abfc6f35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lithotomy AirShuttle™
• Version Model Number: RT-5100-05
• Catalog Number: RT-5100-05
• Company DUNS: 808875397
• Company Name: Qfix
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841962111277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160627

FDA Product Code

• OUO: Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

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: 2021-10-06
• Device Publish Date: 2021-09-28

Devices Manufactured by Qfix

• 10841962107386 - Aquaplast PS™: 2023-12-11 Blush, 1/16" - 3" x 3" Nasal Splint Blanks
• 10841962107409 - Aquaplast PS™: 2023-12-11 Blush, 1/16" Small Silver splint, pkg. of 10
• 10841962107423 - Aquaplast PS™: 2023-12-11 Blush, 1/16" Large Silver splint, pkg. of 10
• 10841962107447 - Aquaplast PS™: 2023-12-11 Blush, 1/16" Tie Down Dressings, 6" x 9" sheet
• 10841962107461 - Aquaplast PS™: 2023-12-11 Blush, 1/16", Trapezoidal Nasal Splint, pkg. of 10
• 10841962107485 - Aquaplast PS™: 2023-12-11 Blush, 1/16", Trapezoidal Nasal Splints
• 10841962107492 - Aquaplast PS™: 2023-12-11 Blush, 3/32", 3 x 3" Nasal Splint Blanks
• 10841962107515 - Aquaplast PS™: 2023-12-11 Blush, 3/32", 18" x 24" sheet