SHERIDAN 5-10316

GUDID 34026704759263

ET TUBE, HVT, 8.0

TELEFLEX INCORPORATED

Basic endotracheal tube, single-use

• Primary Device ID: 34026704759263
• NIH Device Record Key: ed921d0d-c02d-4153-9915-1b893cdfe3f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHERIDAN
• Version Model Number: IPN926931
• Catalog Number: 5-10316
• Company DUNS: 002348191
• Company Name: TELEFLEX INCORPORATED
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM

Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *None
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
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• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *None
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
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• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
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• Special Storage Condition, Specify: Between 0 and 0 *None
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *None
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
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• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
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• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
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• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *None
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *None
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• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *None
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *None
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *None
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *None

Device Identifiers

Device Issuing Agency	Device ID
GS1	14026704759269 [Primary]
GS1	24026704759266 [Package]; Contains: 14026704759269; Package: Box [10 Units]; In Commercial Distribution
GS1	34026704759263 [Package]; Contains: 24026704759266; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K822082

FDA Product Code

• BTR: Tube, tracheal (w/wo connector)

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: 2023-02-14
• Device Publish Date: 2023-02-06

On-Brand Devices [SHERIDAN]

• 34026704759386: ET TUBE, UNCUFFED, 6.0
• 34026704759379: ET TUBE, UNCUFFED, 5.5
• 24026704759365: ET TUBE, UNCUFFED, 5.0
• 34026704759355: ET TUBE, UNCUFFED, 4.5
• 34026704759348: ET TUBE, UNCUFFED, 4.0
• 24026704759334: ET TUBE, UNCUFFED, 3.5
• 24026704759327: ET TUBE, UNCUFFED, 3.0
• 34026704759317: ET TUBE, UNCUFFED, 2.5
• 34026704759300: ET TUBE, UNCUFFED, 2.0
• 24026704759280: ET TUBE, HVT, 9.0
• 24026704759273: ET TUBE, HVT, 8.5
• 34026704759263: ET TUBE, HVT, 8.0
• 34026704759256: ET TUBE, HVT, 7.5
• 34026704759249: ET TUBE, HVT, 7.0
• 34026704759232: ET TUBE, HVT, 6.5
• 34026704759225: ET TUBE, HVT, 6.0
• 34026704759218: 71 TUBE, HVT, 5.5
• 24026704759204: ET TUBE, HVT, 5.0
• 24026704759181: ET TUBE,CF,9.5
• 24026704759174: ET TUBE,CF,9.0
• 24026704759167: ET TUBE,CF,8.5
• 24026704759150: ET TUBE,CF,8.0
• 34026704759140: ET TUBE,CF,7.5
• 34026704759133: ET TUBE,CF,7.0
• 24026704759129: ET TUBE,CF,6.5
• 34026704759119: ET TUBE,CF,6.0
• 34026704759102: ET TUBE,CF,5.5
• 34026704759096: ET TUBE,CF,5.0
• 24026704759082: ET TUBE,CF,4.5
• 24026704759075: ET TUBE,CF,4.0
• 24026704759068: ET TUBE,CF,3.5
• 34026704759058: ET TUBE,CF,3.0
• 24026704760002: ET TUBE,LTS,6.0
• 34026704759997: ET TUBE,LTS,5.0
• 34026704759980: ET TUBE,LTS,4.0
• 34026704759928: ET TUBE, CUFFED, SPIRAL-FLEX 9.0
• 34026704759911: ET TUBE, CUFFED, SPIRAL-FLEX 8.5
• 24026704759907: ET TUBE, CUFFED, SPIRAL-FLEX 8.0
• 34026704759898: ET TUBE, CUFFED, SPIRAL-FLEX 7.5
• 34026704759881: ET TUBE, CUFFED, SPIRAL-FLEX 7.0
• 34026704759874: ET TUBE, CUFFED, SPIRAL-FLEX 6.5
• 24026704759860: ET TUBE, CUFFED, SPIRAL-FLEX 6.0
• 34026704759850: ET TUBE, CUFFED, SPIRAL-FLEX 5.5
• 24026704759846: ET TUBE, CUFFED, SPIRAL-FLEX 5.0
• 24026704759792: ET TUBE,CUFFED ORAL,SPIRAL-FLEX 7.0
• 24026704759730: ET TUBE, PREFORMED CUFFED NASAL, 7.5
• 24026704759723: ET TUBE, PREFORMED CUFFED NASAL, 7.0
• 34026704759713: ET TUBE, PREFORMED CUFFED NASAL, 6.5
• 24026704759709: ET TUBE, PREFORMED CUFFED NASAL, 6.0
• 34026704759683: ET TUBE, PREFORMED CUFFED ORAL, 8.5