V-Cath 380-01

GUDID B339380015

4.0Fr / 5.0Fr V-Cath Repair Kit

NEO MEDICAL INC.

Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter

• Primary Device ID: B339380015
• NIH Device Record Key: 2e1e3e88-9473-454c-90ac-f6c38f125a92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-Cath
• Version Model Number: 380-01
• Catalog Number: 380-01
• Company DUNS: 015510540
• Company Name: NEO MEDICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B339380010 [Primary]
HIBCC	B339380015 [Package]; Contains: B339380010; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953300

FDA Product Code

• LJS: Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

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: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [V-Cath]

• B3395081625: 5.0Fr x 20cm Single Lumen Midline with Safety OTN
• B3395071665: 5.0Fr x 60cm Single Lumen PICC with Insertion Components
• B33950530035: 5.0Fr x 10cm Tearaway Sheath Dilator Introducer Set
• B339502926605: 5.0Fr x 60cm Dual Lumen PICC with MST Insertion Components
• B339502916605: 5.0Fr x 60cm Single Lumen PICC with MST Insertion Components
• B33950291625: 5.0Fr x 20cm Single Lumen Midline with MST
• B33950290035: 5.0Fr x 5cm Modified Seldinger Introducer Kit
• B3395000085: 5.0Fr x 10cm IR Seldinger Introducer Kit
• B3394081625: 4.0Fr x 20cm Single Lumen Midline with Safety OTN
• B3394071665: 4.0Fr x 60cm Single Lumen PICC with Insertion Components
• B33940530035: 4.0Fr x 10cm Tearaway Sheath Dilator Introducer Set
• B33940291625: 4.0Fr x 20cm Single Lumen Midline with MST
• B33940290035: 4.0Fr x 5cm Modified Seldinger Introducer Kit
• B3394000085: 4.0Fr x 10cm IR Seldinger Introducer Kit
• B399390765: 5.0Fr x 60cm Dual Lumen PICC with Stylet and OTN Introducer
• B3393903005: 5.0Fr (15ga) Sharps Safety Tearaway Sheath Introducer
• B339390255: 5.0Fr Sheath Introducer
• B339385755: 5.0Fr x 60cm Single Lumen PICC with Stylet and OTN Introducer
• B339380785: 4.0Fr x 20cm Single Lumen Midline with Stylet and OTN Introducer
• B339380755: 4.0Fr x 60cm Single Lumen PICC with Stylet and OTN Introducer
• B3393803005: 4.0Fr (17ga) Sharps Safety Tearaway Sheath Introducer
• B339380255: 4.0Fr Sheath Introducer
• B339380015: 4.0Fr / 5.0Fr V-Cath Repair Kit
• B339360785: 3.0Fr x 20cm Single Lumen Midline with Stylet and OTN Introducer
• B339360255: 3.0 Fr Sheath Introducer
• B3393081620: 3.0Fr x 20cm Single Lumen Midline with Safety OTN
• B3393041665: 3.0Fr x 60cm Single Lumen PICC with Stylet and OTN Introducer
• B33930291625: 3.0Fr x 20cm Single Lumen Midline with MST