RUSCH 102004-000050

GUDID 24026704002652

Endotracheal tube for laser surgery

TELEFLEX INCORPORATED

Laser-resistant endotracheal tube

• Primary Device ID: 24026704002652
• NIH Device Record Key: ed293330-fedd-45fd-8866-9370abb3581c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RUSCH
• Version Model Number: IPN040898
• Catalog Number: 102004-000050
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• 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
• 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

• Device Size Text, specify: 0
• Lumen/Inner Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 5 Millimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight; Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight; Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight; Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight; Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight; Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight; Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight; Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight; Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight; Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight; Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight; Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight; Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight; Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight; Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight; Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight; Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight; Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight; Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	04026704002658 [Primary]
GS1	24026704002652 [Package]; Contains: 04026704002658; Package: Box [2 Units]; In Commercial Distribution
GS1	44026704002656 [Package]; Package: Carton [46 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935842

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-06-03
• Device Publish Date: 2015-10-16

On-Brand Devices [RUSCH]

• 24026704550191: 1" Foam Straps
• 24026704549843: One Piece Medium Catheter w/o Tape
• 24026704549836: One Piece Regular Catheter w/o Tape
• 44026704546723: PVC NASOPHARYNGEAL AIRWAY KIT, STERILE
• 44026704546716: PVC NASOPHARYNGEAL AIRWAY KIT, STERILE
• 44026704546709: Ultra Robertazzi Nasopharyngeal Airway Kit, Sterile
• 44026704546693: Ultra Robertazzi Nasopharyngeal Airway Kit, Sterile
• 44026704094088: PERCUQUICK TRACHEOSTOMY SET, STERILE
• 44026704094071: PERCUQUICK TRACHEOSTOMY SET, STERILE
• 44026704094064: PERCUQUICK TRACHEOSTOMY SET, STERILE
• 44026704067624: Silkospray
• 44026704066122: Adhesive patch, big
• 04026704063390: Standard connector 15 mm
• 04026704063369: Standard connector 15 mm
• 04026704063352: Standard connector 15 mm
• 04026704063345: Standard connector 15 mm
• 04026704063338: Standard connector 15 mm
• 04026704063321: Standard connector 15 mm
• 04026704063314: Standard connector 15 mm
• 04026704063307: Standard connector 15 mm
• 04026704063291: Standard connector 15 mm
• 04026704063284: Standard connector 15 mm
• 04026704063277: Standard connector 15 mm
• 04026704063260: Standard connector 15 mm
• 04026704063253: Standard connector 15 mm
• 04026704063246: Standard connector 15 mm
• 34026704063230: Standard connector 15 mm
• 34026704063223: Standard connector 15 mm
• 34026704063216: Standard connector 15 mm
• 34026704063209: Standard connector 15 mm
• 34026704063193: Standard connector 15 mm
• 34026704063186: Standard connector 15 mm
• 34026704063179: Standard connector 15 mm
• 04026704058464: Rectal tube, 50 cm, open tip, 1 eye
• 04026704058457: Rectal tube, 50 cm, open tip, 1 eye
• 04026704058440: Rectal tube, 50 cm, open tip, 1 eye
• 04026704058433: Rectal tube, 50 cm, open tip, 1 eye
• 04026704058426: Rectal tube, 50 cm, open tip, 1 eye
• 04026704058419: Rectal tube, 50 cm, open tip, 1 eye
• 44026704058400: Rectal tube, 50 cm, open tip, 1 eye
• 44026704058394: Rectal tube, 50 cm, open tip, 1 eye
• 44026704058387: Rectal tube, 50 cm, open tip, 1 eye
• 44026704058370: Rectal tube, 50 cm, open tip, 1 eye
• 44026704058363: Rectal tube, 50 cm, open tip, 1 eye
• 44026704058356: Rectal tube, 50 cm, open tip, 1 eye
• 44026704058349: Rectal tube, 50 cm, open tip, 1 eye
• 44026704017834: Face mask for anesthesia, pediatric
• 44026704017827: Face mask for anesthesia, pediatric
• 44026704017810: Face mask for anesthesia, pediatric
• 44026704017803: Face mask for anesthesia, pediatric