V-Cath 390-300
GUDID B3393903005
5.0Fr (15ga) Sharps Safety Tearaway Sheath Introducer
NEO MEDICAL INC.
Vascular catheter introduction set, nonimplantable| Primary Device ID | B3393903005 |
| NIH Device Record Key | 91cf591f-53f3-4603-8047-b5c4e00c96b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | V-Cath |
| Version Model Number | 390-300 |
| Catalog Number | 390-300 |
| Company DUNS | 015510540 |
| Company Name | NEO MEDICAL INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
Device Dimensions
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Needle Gauge | 16 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 16 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 16 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 16 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 16 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 16 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 16 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 16 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 16 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 16 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 16 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 16 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 16 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 16 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 16 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 16 Gauge |
| Catheter Gauge | 5 French |
| Needle Gauge | 16 Gauge |
| 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 | B3393903000 [Primary] |
| HIBCC | B3393903005 [Package] Contains: B3393903000 Package: Case [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K022099
FDA Product Code
| FOZ | Catheter,Intravascular,Therapeutic,Short-Term Less 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 | 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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