TELEFLEX 21096100

GUDID 44026704331114

RUSCH MMG H2O: Hydrophilic closed-system intermittent catheter

TELEFLEX INCORPORATED

Single-administration urethral drainage catheter

• Primary Device ID: 44026704331114
• NIH Device Record Key: 0b75445c-b02c-4c50-87e8-eb9a0a0473f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TELEFLEX
• Version Model Number: IPN050841
• Catalog Number: 21096100
• 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: false
• 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

Device Dimensions

• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04026704331116 [Primary]
GS1	44026704331114 [Package]; Contains: 04026704331116; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020714

FDA Product Code

• GBM: CATHETER, URETHRAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-07-18
• Device Publish Date: 2016-09-16

On-Brand Devices [TELEFLEX]

• 44026704588457: TFX ISIS HVT WITH STYLETT 9.0
• 44026704588440: TFX ISIS HVT WITH STYLET 8.5
• 44026704588433: TFX ISIS HVT WITH STYLET 8.0
• 24026704588422: TFX ISIS HVT WITH STYLET 7.5
• 44026704588419: TFX ISIS HVT WITH STYLET 7.0
• 44026704588402: TFX ISIS HVT WITH STYLET 6.5
• 24026704588392: TFX ISIS HVT WITH STYLET 6.0
• 44026704588389: TFX ISIS SUBGLOTTIC SEC. ETT, 9.0
• 24026704588378: TFX ISIS SUBGLOTTIC SEC. ETT, 8.5
• 24026704588361: TFX ISIS SUBGLOTTIC SEC. ETT, 8.0
• 44026704588358: TFX ISIS SUBGLOTTIC SEC. ETT, 7.5
• 44026704588341: TFX ISIS SUBGLOTTIC SEC. ETT, 7.0
• 24026704588330: TFX ISIS SUBGLOTTIC SEC. ETT, 6.5
• 44026704588327: TFX ISIS SUBGLOTTIC SEC. ETT, 6.0
• 14026704667984: Endo Applier XLarge, Curved 18"
• 14026704667960: Endo Remover Large - XLarge, Straight 18"
• 14026704667946: Endo Applier Large, Curved 18"
• 14026704667922: Endo Remover Med/Large - Large, Straight 18"
• 14026704667908: Endo Applier Med/Large, Straight 18"
• 14026704667885: Endoscopic Applier, Large - 45
• 14026704667878: Endoscopic Applier, Med Large - 45
• 14026704667861: Applier XLarge, Curved 13"
• 14026704667847: Endo Remover Large - XLarge, Straight 13"
• 14026704667823: Endo Applier Large, Curved 13"
• 14026704667809: Endo Remover Med/Large - Large, Straight 13"
• 14026704667786: Endo Applier Med/Large, Straight 13"
• 14026704667762: Endoscopic Applier, Large - 33
• 14026704667755: Vesocclude Applier Medium Large Endoscopic Curved Diameter 10/11 Millimeter Length 13 Inch
• 14026704667748: Vesocclude Applier Medium Endoscopic Curved Diameter 7 Millimeter Length 13 Inch 280 Millimeter
• 14026704667731: Applier XLarge, 70 Degree 11"
• 14026704667717: Applier XLarge, Curved 11"
• 14026704667694: Remover Large - XLarge, Straight 11"
• 14026704667670: Applier Large, 70 Degree 8"
• 14026704667656: Applier Large, Curved 8"
• 14026704667632: Applier Large, 70 Degree 11"
• 14026704667397: Applier Large, Curved 11"
• 14026704667373: Applier Med/Large, 70 Degree 8"
• 14026704667359: Applier Med/Large, Curved 8"
• 14026704667335: Applier Med/Large, 70 Degree 11"
• 14026704667311: Applier Med/Large, Curved 11"
• 14026704667298: Remover Med/Large - Large, Straight 11"
• 14026704667274: Applier Medium, Curved 8"
• 14026704667250: Applier Medium, 70 Degree 11"
• 14026704667236: Applier Medium, Curved 11"
• 14026704667212: Remover Medium - Large, Straight 11"
• 44026704667190: Extra Large Clips - 20 Boxes/1 Case
• 14026704667175: Applier, Large - 8 - 55
• 14026704667168: Applier, Large - 8
• 14026704667151: Applier, Large - 11 - 70
• 14026704667144: Applier, Large - 11 - 55