Home GUDID M991IK522212 Valved Introducer
Primary DI M991IK522212
Brand Valved Introducer
Company NORFOLK MEDICAL
Model Flowguard
Catalog number IK52221
Device description 8F Valved Introducer Kit
Published 2015-09-01
Public version status Update
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 DYB INTRODUCER, CATHETER
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DYB Introducer, Catheter Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M991IK522212 Package HIBCC 2 In Commercial Distribution M991IK522211 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Vascular catheter introduction set, nonimplantable A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 15 Centimeter
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 013861471 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M991IK312211 Standard Introducer Straight Wing Tearaway IK31221 2015-09-01 M991IK512211 Standard Introducer Straight Wing Tearaway IK51221 2015-09-01 M991IK522211 Valved Introducer Flowguard IK52221 2015-09-01 M991IK712211 Standard Introducer Straight Wing Tearaway IK71221 2015-09-01 M991IK722211 Valved Introducer Flowguard IK72221 2015-09-01 M991IK812211 Standard Introducer Straight Wing Tearaway IK81221 2015-09-01 M991CVS611101 Clear-View Subcutaneous Infusion Set "Clear-View ""Sub-Q""" CVS61110 2021-11-18 M991CVS612101 Clear-View Subcutaneous Infusion Set "Clear-View ""Sub-Q""" CVS61210 2021-11-18 M991CVS615101 Clear-View Subcutaneous Infusion Set "Clear-View ""Sub-Q""" CVS61510 2021-11-18 M991CVS622101 Clear-View Subcutaneous Infusion Set "Clear-View ""Sub-Q""" CVS62210 2021-11-18 M991CVS611102 Clear-View Subcutaneous Infusion Set Clear-View "Sub-Q" CVS61110 2021-11-18 M991CVS612102 Clear-View Subcutaneous Infusion Set Clear-View "Sub-Q" CVS61210 2021-11-18 M991CVS615102 Clear-View Subcutaneous Infusion Set Clear-View "Sub-Q" CVS61510 2021-11-18 M991CVS622301 Clear-View Subcutaneous Infusion Set "Clear-View ""Sub-Q""" CVS62230 2021-11-04 M991SCIG331361 Clear-View Multi-site Subcutaneous Infusion Set ClearView™MS SCIG33136 2020-10-19 M991TH011001 Tidal High-Flow Non-coring Needle Tidal-HF TH01100 2015-10-06 M991TH012001 Tidal High-Flow Non-coring Needle Tidal-HF TH01200 2015-10-06 M991TH013001 Tidal High-Flow Non-coring Needle Tidal-HF TH01300 2015-10-06 M991TH021001 Tidal High-Flow Non-coring Needle Tidal-HF TH02100 2015-10-06 M991TH022001 Tidal High-Flow Non-coring Needle Tidal-HF TH02200 2015-10-06
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published G440VIZ1750 Multiflex Vizaramed, Inc. DYB 2026-04-09 08498840011300 VYGON Vygon Corporation DYB 2019-04-08 08498840011317 VYGON Vygon Corporation DYB 2019-04-08 08498840011751 VYGON Vygon Corporation DYB 2019-04-08 08498840011768 VYGON Vygon Corporation DYB 2019-04-08 08498840011775 VYGON Vygon Corporation DYB 2019-04-08 08498840011782 VYGON Vygon Corporation DYB 2019-04-08 08498840011799 VYGON Vygon Corporation DYB 2019-04-08 08498840011805 VYGON Vygon Corporation DYB 2019-04-08 08498840011812 VYGON Vygon Corporation DYB 2019-04-08 08498840012215 VYGON Vygon Corporation DYB 2019-04-08 H965481030 ENVI NAVILYST MEDICAL, INC. DYB 2019-01-03 07613327459210 AXS VECTA 71 Stryker Corporation DYB 2018-10-26 07613327459227 AXS VECTA 71 Stryker Corporation DYB 2018-10-26 07613327459234 AXS VECTA 71 Stryker Corporation DYB 2018-10-26 H965481080 Navylist NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355010 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355020 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355030 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355060 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355080 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355090 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355110 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355120 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355130 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355160 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355170 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355180 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355190 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965481000 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07
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