NeoMagic 3053-003
GUDID B33930530035
3.0Fr x 10cm Tearaway Sheath Dilator Introducer Set
NEO MEDICAL INC.
Vascular catheter introduction set, nonimplantable| Primary Device ID | B33930530035 |
| NIH Device Record Key | 36873c32-87ee-404d-a305-8a9293ee73e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeoMagic |
| Version Model Number | 3053-003 |
| Catalog Number | 3053-003 |
| 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 | 3 French |
| Catheter Gauge | 3 French |
| Catheter Gauge | 3 French |
| Catheter Gauge | 3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 3 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 | B33930530030 [Primary] |
| HIBCC | B33930530035 [Package] Contains: B33930530030 Package: Case [5 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 [NeoMagic]
| B339914125 | 0.018" x 60cm SS/Tungsten Guide-wire |
| B339914115 | 0.018" x 60cm NiTi/SS Guide-wire |
| B339914105 | Repositioning Deflection .010" x 60cm Hydrophillic Coated Wire |
| B339914085 | Repositioning Deflection .008" x 60cm Hydrophillic Coated Wire |
| B339407616085 | 4.0Fr (18ga) x 8cm Single Lumen EPIV with Stylet and Introducer |
| B339404316085 | 4.0Fr (18ga) x 8cm Single Lumen EPIV with Stylet |
| B339402916605 | 4.0Fr x 60cm Single Lumen PICC with MST |
| B339392926605 | 3.9Fr Dual Lumen PICC with MST |
| B339392926505 | 3..9 x 50cm Dual Lumen PICC with staggered ports and MST |
| B3393603005 | 3.0Fr (19ga) Sharps Safety Tearaway Sheath Introducer |
| B339360015 | 3.0Fr V-Cath Repair Kit |
| B339355755 | 1.9 Fr/23 ga, 40cm, Single Lumen PICC with E-Z Flush Stylet |
| B339355725 | 2.0 Fr/ 23 ga, 25cm, Single Lumen PICC with E-Z Flush Stylet |
| B339355705 | 1.9 Fr/23 ga, 40cm, Single Lumen PICC with E-Z Flush Stylet |
| B339352526605 | 3.5Fr x 60cm Dual Lumen PICC, MST |
| B339352516605 | 3.5Fr x 60cm Single Lumen PICC, MST |
| B3393503005 | 1.9/2.0 Fr Push Button Sharps Safety Needle & Tearaway Sheath Introducer |
| B339350255 | 1.9 / 2.0Fr Needle & Tearaway Sheath Introducer |
| B339350200 | 1.9/2.0 Fr Breakaway Needle Introducer |
| B339350015 | 1.9Fr & 2.0Fr Repair Kit |
| B339350005 | 1.9Fr x 40cm SL PICC with Breakaway Introducer and Insertion Kit |
| B339309116405 | 3.0Fr x 40cm Single Lumen Power Rated PICC with MST |
| B339307616085 | 3.0Fr (20ga) x 8cm Single Lumen EPIV with Stylet and Introducer |
| B3393071665 | 3.0Fr Single Lumen PICC with Insertion Components |
| B33930580045 | 2.5Fr / 3.0Fr x 3cm Mini Modified Seldinger Kit |
| B33930530035 | 3.0Fr x 10cm Tearaway Sheath Dilator Introducer Set |
| B339304316085 | 3.0Fr (20ga) x 8cm Single Lumen EPIV with Stylet |
| B339302916600 | 3.0Fr Single Lumen PICC with Stylet and MST |
| B33930290035 | 3.0Fr x 5cm Modified Seldinger Introducer Kit |
| B339302516605 | 3.0Fr x 60cm Single Lumen PICC, with MST |
| B3393001665 | 3.0Fr x 60cm Single Lumen PICC, 10cm Tearaway, 0.018 x 80cm guide-wire, 7cm Safety GWI |
| B3393000085 | 3.0Fr x 10cm IR Introducer Seldinger Kit |
| B339252516505 | 2.5Fr x 50cm Single Lumen PICC with Mini MST |
| B33920964005 | 1.9/2.0 Fr, 27ga, Needle & Tearaway Sheath Introducer |
| B33920763000 | 1.9/2.0 Fr, 27ga, Sharps Safety Needle & Tearaway Sheath Introducer |
| B339197616085 | 1.9Fr x 8cm Single Lumen EPIV w Stylet & 27ga Sharps Safety Tearaway Sheath Introducer |
| B339197616065 | 1.9Fr x 6cm Single Lumen EPIV w Stylet & 27ga Sharps Safety Tearaway Sheath Introducer |
| B33919580045 | 1.9/2.0 Fr, 30ga Modified Seldinger Introductor Kit |
| B339194416405 | 1.9Fr x 40cm, Single Lumen PICC w/o stylet |
| B339194416255 | 1.9Fr x 25cm, Single Lumen PICC w/o stylet |
| B339194316405 | 1.9Fr x 40cm, Single Lumen PICC with Stylet |
| B339194316255 | 1.9Fr x 25cm, Single Lumen PICC with Stylet |
| B339194316085 | 1.9Fr x 8cm Single Lumen EPIV with Stylet (Catheter Only) |
| B339194316065 | 1.9Fr x 6cm Single Lumen EPIV with Stylet (Catheter Only) |
| B339194216400 | 1.9Fr x 40CM Single Lumen PICC w/Stylet and Sharps Safety Tearaway Introducer |
| B339194716085 | 1.9Fr x 8cm Single Lumen Polyurethane EPIV with Stylet & 27ga Sharps Safety Tearaway Sheath Intr |
| B339194716065 | 1.9Fr x 6cm Single Lumen Polyurethane EPIV with Stylet & 27ga Sharps Safety Tearaway Sheath Intr |
| B339194616405 | 1.9Fr x 40cm Single Lumen Polyurethane PICC with Stylet |
| B339194616250 | 1.9Fr x 25cm Single Lumen Polyurethane PICC with Stylet |
| B339194616085 | 1.9Fr x 8cm Single Lumen Polyurethane EPIV with Stylet (Catheter Only) |
Trademark Results [NeoMagic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEOMAGIC 86306385 4678457 Live/Registered |
Neo Medical Inc 2014-06-11 |
 NEOMAGIC 78753685 3220826 Dead/Cancelled |
NEO MEDICAL INC. 2005-11-14 |
 NEOMAGIC 77301498 3435718 Dead/Cancelled |
NeoMagic Corp. 2007-10-11 |
 NEOMAGIC 75053462 2028840 Dead/Cancelled |
NeoMagic Corporation 1996-02-05 |
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