RUSCH RONC-16

GUDID 24026704551280

16FR Red Rubber

TELEFLEX INCORPORATED

Indwelling urethral drainage catheter

• Primary Device ID: 24026704551280
• NIH Device Record Key: 9f38bde0-c45b-4216-a9ed-8d0639b369ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RUSCH
• Version Model Number: IPN053694
• Catalog Number: RONC-16
• 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

Device Dimensions

• Length: 11 Inch
• Width: 6.5 Inch
• Height: 0.5 Inch
• Length: 11 Inch
• Width: 6.5 Inch
• Height: 0.5 Inch
• Length: 11 Inch
• Width: 6.5 Inch
• Height: 0.5 Inch
• Length: 11 Inch
• Width: 6.5 Inch
• Height: 0.5 Inch
• Length: 11 Inch
• Width: 6.5 Inch
• Height: 0.5 Inch
• Length: 11 Inch
• Width: 6.5 Inch
• Height: 0.5 Inch
• Length: 11 Inch
• Width: 6.5 Inch
• Height: 0.5 Inch
• Length: 11 Inch
• Width: 6.5 Inch
• Height: 0.5 Inch
• Length: 11 Inch
• Width: 6.5 Inch
• Height: 0.5 Inch
• Length: 11 Inch
• Width: 6.5 Inch
• Height: 0.5 Inch
• Length: 11 Inch
• Width: 6.5 Inch
• Height: 0.5 Inch
• Length: 11 Inch
• Width: 6.5 Inch
• Height: 0.5 Inch
• Length: 11 Inch
• Width: 6.5 Inch
• Height: 0.5 Inch
• Length: 11 Inch
• Width: 6.5 Inch
• Height: 0.5 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *false
• Special Storage Condition, Specify: Between 0 and 0 *false
• Special Storage Condition, Specify: Between 0 and 0 *false
• Special Storage Condition, Specify: Between 0 and 0 *false
• Special Storage Condition, Specify: Between 0 and 0 *false
• Special Storage Condition, Specify: Between 0 and 0 *false
• Special Storage Condition, Specify: Between 0 and 0 *false
• Special Storage Condition, Specify: Between 0 and 0 *false
• Special Storage Condition, Specify: Between 0 and 0 *false
• Special Storage Condition, Specify: Between 0 and 0 *false
• Special Storage Condition, Specify: Between 0 and 0 *false
• Special Storage Condition, Specify: Between 0 and 0 *false
• Special Storage Condition, Specify: Between 0 and 0 *false
• Special Storage Condition, Specify: Between 0 and 0 *false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04026704551286 [Primary]
GS1	24026704551280 [Package]; Contains: 04026704551286; Package: Box [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010420

FDA Product Code

• KOD: CATHETER, UROLOGICAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 9
• Public Version Date: 2020-12-04
• Device Publish Date: 2016-09-16

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