V-Cath 5053-003
GUDID B33950530035
5.0Fr x 10cm Tearaway Sheath Dilator Introducer Set
NEO MEDICAL INC.
Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable| Primary Device ID | B33950530035 |
| NIH Device Record Key | 4b3a9833-81ac-49e9-b497-98b467add9f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | V-Cath |
| Version Model Number | 5053-003 |
| Catalog Number | 5053-003 |
| Company DUNS | 015510540 |
| Company Name | NEO MEDICAL INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 |
| support@neomedicalinc.com | |
| Phone | 888-450-3334 |
| support@neomedicalinc.com | |
| Phone | 888-450-3334 |
| support@neomedicalinc.com | |
| Phone | 888-450-3334 |
| support@neomedicalinc.com | |
| Phone | 888-450-3334 |
| support@neomedicalinc.com | |
| Phone | 888-450-3334 |
| support@neomedicalinc.com | |
| Phone | 888-450-3334 |
| support@neomedicalinc.com | |
| Phone | 888-450-3334 |
| support@neomedicalinc.com | |
| Phone | 888-450-3334 |
| support@neomedicalinc.com | |
| Phone | 888-450-3334 |
| support@neomedicalinc.com | |
| Phone | 888-450-3334 |
| support@neomedicalinc.com | |
| Phone | 888-450-3334 |
| support@neomedicalinc.com | |
| Phone | 888-450-3334 |
| support@neomedicalinc.com | |
| Phone | 888-450-3334 |
| support@neomedicalinc.com | |
| Phone | 888-450-3334 |
| support@neomedicalinc.com | |
| Phone | 888-450-3334 |
| support@neomedicalinc.com | |
| Phone | 888-450-3334 |
| support@neomedicalinc.com | |
| Phone | 888-450-3334 |
| support@neomedicalinc.com | |
| Phone | 888-450-3334 |
| support@neomedicalinc.com |
Device Dimensions
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Catheter Gauge | 5 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 | B33950530030 [Primary] |
| HIBCC | B33950530035 [Package] Contains: B33950530030 Package: Case [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K951384
FDA Product Code
| KZH | Introducer, Syringe Needle |
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 | 2019-06-07 |
| 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 |
Trademark Results [V-Cath]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 V-CATH 76187003 2506689 Dead/Cancelled |
NEO MEDICAL INC. 2000-12-27 |
 V-CATH 74014806 1656725 Dead/Cancelled |
HDC CORPORATION 1989-12-28 |
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