MEDADV M95R0721S
GUDID 00819667020753
ONSET RADIAL INTRODUCER KIT 5 Fr
MEDAS 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 | 00819667020753 |
| NIH Device Record Key | a7556915-9ca0-4b36-b5ca-1f7c272a26fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MEDADV |
| Version Model Number | M95R50721S |
| Catalog Number | M95R0721S |
| Company DUNS | 080593067 |
| Company Name | MEDAS INC |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(786)832-0459 |
| customerservice@medausa.com | |
| Phone | +1(786)832-0459 |
| customerservice@medausa.com | |
| Phone | +1(786)832-0459 |
| customerservice@medausa.com | |
| Phone | +1(786)832-0459 |
| customerservice@medausa.com | |
| Phone | +1(786)832-0459 |
| customerservice@medausa.com | |
| Phone | +1(786)832-0459 |
| customerservice@medausa.com | |
| Phone | +1(786)832-0459 |
| customerservice@medausa.com | |
| Phone | +1(786)832-0459 |
| customerservice@medausa.com | |
| Phone | +1(786)832-0459 |
| customerservice@medausa.com | |
| Phone | +1(786)832-0459 |
| customerservice@medausa.com | |
| Phone | +1(786)832-0459 |
| customerservice@medausa.com | |
| Phone | +1(786)832-0459 |
| customerservice@medausa.com | |
| Phone | +1(786)832-0459 |
| customerservice@medausa.com | |
| Phone | +1(786)832-0459 |
| customerservice@medausa.com | |
| Phone | +1(786)832-0459 |
| customerservice@medausa.com | |
| Phone | +1(786)832-0459 |
| customerservice@medausa.com | |
| Phone | +1(786)832-0459 |
| customerservice@medausa.com | |
| Phone | +1(786)832-0459 |
| customerservice@medausa.com | |
| Phone | +1(786)832-0459 |
| customerservice@medausa.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00819667020753 [Primary] |
| GS1 | 10819667020750 [Package] Package: [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123475
FDA Product Code
| DYB | Introducer, Catheter |
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 | 2019-06-07 |
| Device Publish Date | 2018-04-09 |
On-Brand Devices [MEDADV]
| 00819667021057 | DISPOSABLE ANAESTHESIA AIR CUSHION MASK SIZE EXTRA LARGE |
| 00819667021040 | DISPOSABLE ANAESTHESIA AIR CUSHION MASK LARGE ADULT |
| 00819667021033 | DISPOSABLE ANAESTHESIA AIR CUSHION MASK SIZE MEDIUM ADULT |
| 00819667021026 | DISPOSABLE ANAESTHESIA AIR CUSHION MASK SIZE SMALL ADULT |
| 00819667021019 | DISPOSABLE ANAESTHESIA AIR CUSHION MASK PEDIATRIC |
| 00819667021002 | DISPOSABLE ANAESTHESIA AIR CUSHION MASK INFANT |
| 00819667020999 | DISPOSABLE ANAESTHESIA AIR CUSHION MASK NEONATE |
| 10819667020989 | URINARY DRAINAGE LUXURY BAG Contents: One each 2000mL drainage bag equipped with Anti-reflux ch |
| 00819667020852 | ENCOURAGE PTCA BALLOON CATHETER 3.0 mm X 20 mm RAPID EXCHANGE |
| 10819667020866 | PRESS RADIAL ARTERY TOURNIQUET SIZE LARGE |
| 10819667020804 | PRESS RADIAL ARTERY TOURNIQUET SIZE MEDIUM |
| 10819667020798 | PRESS RADIAL ARTERY TOURNIQUET SIZE EXTRA LARGE |
| 10819667020781 | PRESS RADIAL ARTERY TOURNIQUET SIZE SMALL |
| 00819667020753 | ONSET RADIAL INTRODUCER KIT 5 Fr |
| 00819667020746 | ONSET FEMORAL INTRODUCER KIT 6 Fr |
| 00819667020654 | HAULER HYDROPHILIC COATING GUIDEWIRE 0.035" X 260 cm |
| 00819667020647 | HAULER HYDROPHILIC COATING GUIDEWIRE 0.035" X 150 cm |
| 00819667020630 | ENCOURAGE PTCA BALLOON CATHETER 4.0mm X 12mm RAPID EXCHANGE |
| 00819667020623 | ENCOURAGE PTCA BALLOON CATHETER 3.0 mm X 26 mm RAPID EXCHANGE |
| 00819667020616 | ENCOURAGE PTCA BALLOON CATHETER 3.0mm X 16mm RAPID EXCHANGE |
| 00819667020609 | ENCOURAGE PTCA BALLOON CATHETER 2.75 mm X 26 mm RAPID EXCHANGE |
| 00819667020593 | ENCOURAGE PTCA BALLOON CATHETER 2.75 mm X 20 mm RAPID EXCHANGE |
| 00819667020586 | ENCOURAGE PTCA BALLOON CATHETER 2.75mm X 16mm RAPID EXCHANGE |
| 00819667020579 | ENCOURAGE PTCA BALLOON CATHETER 2.5mm X 20mm RAPID EXCHANGE |
| 00819667020562 | ENCOURAGE PTCA BALLOON CATHETER 2.0mm X 26mm RAPID EXCHANGE |
| 00819667020555 | ENCOURAGE PTCA BALLOON CATHETER 2.0mm X 20mm RAPID EXCHANGE |
| 00819667020548 | ENCOURAGE PTCA BALLOON CATHETER 2.0 mm X 18 mm RAPID EXCHANGE |
| 00819667020531 | ENCOURAGE PTCA BALLOON CATHETER 2.0 mm X 16 mm RAPID EXCHANGE |
| 00819667020524 | ENCOURAGE PTCA BALLOON CATHETER 2.0mm X 14mm RAPID EXCHANGE |
| 00819667020517 | ENCOURAGE PTCA BALLOON CATHETER 1.75mm X 20mm RAPID EXCHANGE |
| 00819667020500 | ENCOURAGE PTCA BALLOON CATHETER 1.75 mm X 18 mm RAPID EXCHANGE |
| 00819667020494 | ENCOURAGE PTCA BALLOON CATHETER 1.75 mm X 16 mm RAPID EXCHANGE |
| 00819667020487 | ENCOURAGE PTCA BALLOON CATHETER 1.5 mm X 20 mm RAPID EXCHANGE |
| 00819667020470 | ENCOURAGE PTCA BALLOON CATHETER 1.5 mm X 18 mm RAPID EXCHANGE |
| 00819667020463 | ENCOURAGE PTCA BALLOON CATHETER 1.5 mm X 16 mm RAPID EXCHANGE |
| 00819667020456 | ENCOURAGE PTCA BALLOON CATHETER 1.5 mm X 12 mm RAPID EXCHANGE |
| 00819667020289 | CENTRAL VENOUS CATHETER TRIPLE LUMEN 4.5 Fr X 8 CM |
| 00819667020272 | CENTRAL VENOUS CATETHER DOUBLE LUMEN 5 Fr X 8 CM |
| 00819667020265 | CENTRAL VENOUS CATHETER DOUBLE LUMEN 7 Fr X 15 CM |
| 10819667020255 | CENTRAL VENOUS CATETHER TRIPLE LUMEN 7 Fr X 15 CM |
| 10819667020248 | HEMODIALYSIS CATHETER DOUBLE LUMEN 12 Fr X 20 CM |
| 10819667020231 | PERIPHERAL INTRAVENOUS CATHETER 24G X 3/4" |
| 10819667020224 | PERIPHERAL INTRAVENOUS CATHETER 22G X 1" |
| 10819667020217 | PERIPHERAL INTRAVENOUS CATHETER 20G X 1.3" |
| 00819667020197 | DISPOSABLE CO-AXIAL ANAESTHESIA BREATHING CIRCUIT, T PIECE CONNECTOR, ADULT 30MM, 60", 2 L LATEX |
| 00819667020180 | SCALP VEIN INFUSION SET TYPE BUTTERFLY 23G |
| 00819667020173 | SCALP VEIN INFUSION SET TYPE BUTTERFLY 21G |
| 10819667020163 | INTRAVENOUS FLUID ADMINISTRATION SET 150 CM, VENTED, FILTER, Y SITE, NEEDLE 21G X 1 1/2 " |
| 10819667020156 | SYRINGE 3 PARTS LUER LOCK 20 ML WITH NEEDLE 21G X 1 1/2" |
| 10819667020149 | SYRINGE 3 PARTS LUER LOCK 10 ML WITH NEEDLE 21G X 1 1/2" |
Trademark Results [MEDADV]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MEDADV 87264534 5424499 Live/Registered |
JUAN BASALO 2016-12-11 |
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