MEDADV M92125020

GUDID 00819667020579

ENCOURAGE PTCA BALLOON CATHETER 2.5mm X 20mm RAPID EXCHANGE

MEDAS INC

Coronary angioplasty balloon catheter, basic

• Primary Device ID: 00819667020579
• NIH Device Record Key: f1c447a1-9882-48a6-af9b-4fb198aa7b9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDADV
• Version Model Number: M92125020
• Catalog Number: M92125020
• 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
• Email: customerservice@medasusa.com
• Phone: +1(786)832-0459
• Email: customerservice@medasusa.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819667020579 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123473

FDA Product Code

• LOX: Catheters, Transluminal Coronary Angioplasty, Percutaneous

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: 2019-10-07
• Device Publish Date: 2018-04-10

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"