Home GUDID 15051684019873
AngioVac
Primary DI 15051684019873
Brand AngioVac
Company NAVILYST MEDICAL, INC.
Model H965252810
Device description AngioVac Circuit
Published 2020-05-11
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name DWE TUBING, PUMP, CARDIOPULMONARY BYPASS
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DWE Tubing, Pump, Cardiopulmonary Bypass Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status H965252810 Primary HIBCC 0 15051684019873 Secondary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 15051684019873 15051684019873
GMDN Terms# Term, Definition table Term Definition Cardiopulmonary bypass system tubing set A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.
Regulatory Flags# DUNS number 809699023 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published H965252810 AngioVac NAVILYST MEDICAL, INC. DWE 2020-05-11 00616258021539 48” (122 cm) High Pressure Connector Tube BAYER MEDICAL CARE INC. DWE 2019-10-25 00616258008509 48” (122 cm) High Pressure Connector Tube BAYER MEDICAL CARE INC. DWE 2016-12-05 00616258008516 30” (76 cm) High Pressure Connector Tube BAYER MEDICAL CARE INC. DWE 2016-12-05 00616258008523 20” (50 cm) High Pressure Connector Tube BAYER MEDICAL CARE INC. DWE 2016-12-05 00616258008530 10” (25 cm) High Pressure Connector Tube BAYER MEDICAL CARE INC. DWE 2016-12-05 00643169137653 NA MEDTRONIC, INC. DWE 2016-07-23 00613994352811 Intersept® MEDTRONIC, INC. DWE 2016-06-17 00643169169593 NA MEDTRONIC, INC. DWE 2016-06-11 00643169229136 NA MEDTRONIC, INC. DWE 2016-06-11 00643169019287 INTERSEPT® MEDTRONIC, INC. DWE 2016-06-06 00643169029293 NA MEDTRONIC, INC. DWE 2016-06-06 00613994363220 Intersept® MEDTRONIC, INC. DWE 2016-05-28 00613994363237 Intersept® MEDTRONIC, INC. DWE 2016-05-28 00613994407351 INTERSEPT® MEDTRONIC, INC. DWE 2016-05-28 00613994407481 Intersept® MEDTRONIC, INC. DWE 2016-05-28 00613994408426 INTERSEPT® MEDTRONIC, INC. DWE 2016-05-28 00613994408488 Intersept® MEDTRONIC, INC. DWE 2016-05-28 00613994462831 INTERSEPT® MEDTRONIC, INC. DWE 2016-05-28 00613994463494 INTERSEPT® MEDTRONIC, INC. DWE 2016-05-28 00613994851420 INTERSEPT® MEDTRONIC, INC. DWE 2016-05-28 00613994897114 INTERSEPT® MEDTRONIC, INC. DWE 2016-05-28 00613994946317 Intersept® MEDTRONIC, INC. DWE 2016-05-28 00613994946331 Intersept® MEDTRONIC, INC. DWE 2016-05-28 00643169021358 INTERSEPT® MEDTRONIC, INC. DWE 2016-05-28 00643169029125 INTERSEPT® MEDTRONIC, INC. DWE 2016-05-28 00643169061866 INTERSEPT® MEDTRONIC, INC. DWE 2016-05-28 00643169096837 INTERSEPT® MEDTRONIC, INC. DWE 2016-05-28 00643169096905 INTERSEPT® MEDTRONIC, INC. DWE 2016-05-28 00613994097408 NA MEDTRONIC, INC. DWE 2016-05-22