FDA.reportPublic FDA data

Valved Introducer

Primary DI
M991IK722211
Brand
Valved Introducer
Company
NORFOLK MEDICAL
Model
Flowguard
Catalog number
IK72221
Device description
10F 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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M991IK722212PackageHIBCC2In Commercial Distribution
M991IK722211PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of 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
TypeValueUnit
Length15Centimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(847)674-7075npheil@norfolkmedical.com

Regulatory Flags#

DUNS number
013861471
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M991IK312211Standard IntroducerStraight Wing TearawayIK312212015-09-01
M991IK512211Standard IntroducerStraight Wing TearawayIK512212015-09-01
M991IK522211Valved IntroducerFlowguardIK522212015-09-01
M991IK712211Standard IntroducerStraight Wing TearawayIK712212015-09-01
M991IK812211Standard IntroducerStraight Wing TearawayIK812212015-09-01
M991CVS611101Clear-View Subcutaneous Infusion Set"Clear-View ""Sub-Q"""CVS611102021-11-18
M991CVS612101Clear-View Subcutaneous Infusion Set"Clear-View ""Sub-Q"""CVS612102021-11-18
M991CVS615101Clear-View Subcutaneous Infusion Set"Clear-View ""Sub-Q"""CVS615102021-11-18
M991CVS622101Clear-View Subcutaneous Infusion Set"Clear-View ""Sub-Q"""CVS622102021-11-18
M991CVS611102Clear-View Subcutaneous Infusion SetClear-View "Sub-Q"CVS611102021-11-18
M991CVS612102Clear-View Subcutaneous Infusion SetClear-View "Sub-Q"CVS612102021-11-18
M991CVS615102Clear-View Subcutaneous Infusion SetClear-View "Sub-Q"CVS615102021-11-18
M991CVS622301Clear-View Subcutaneous Infusion Set"Clear-View ""Sub-Q"""CVS622302021-11-04
M991SCIG331361Clear-View Multi-site Subcutaneous Infusion SetClearView™MSSCIG331362020-10-19
M991TH011001Tidal High-Flow Non-coring NeedleTidal-HFTH011002015-10-06
M991TH012001Tidal High-Flow Non-coring NeedleTidal-HFTH012002015-10-06
M991TH013001Tidal High-Flow Non-coring NeedleTidal-HFTH013002015-10-06
M991TH021001Tidal High-Flow Non-coring NeedleTidal-HFTH021002015-10-06
M991TH022001Tidal High-Flow Non-coring NeedleTidal-HFTH022002015-10-06
M991TH023001Tidal High-Flow Non-coring NeedleTidal-HFTH023002015-10-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801902193114ARROWTELEFLEX INCORPORATEDDYB2026-07-30
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10801902193190ARROWTELEFLEX INCORPORATEDDYB2026-07-30
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10801902196498ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196511ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196528ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902200768ARROWTELEFLEX INCORPORATEDDYB2026-07-30
06974949033785CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-29
10801902196412ARROWTELEFLEX INCORPORATEDDYB2026-07-29
20801902193470ARROWTELEFLEX INCORPORATEDDYB2026-07-29
10801902189872ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902196436ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902198850ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902226409ARROWTELEFLEX INCORPORATEDDYB2026-07-27
10801902226485ARROWTELEFLEX INCORPORATEDDYB2026-07-22
00850064198676Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
00850064198683Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
10884450114008Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-09
10884450119799Prelude EASE™Merit Medical Systems, Inc.DYB2026-06-09
10884450114855Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-08
00850084947001Genie MAXCULTIV8 1, LLCDYB2026-05-29
G440VIZ1750MultiflexVizaramed, Inc.DYB2026-04-09
04251244502768Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244502775Catapult Guide SheathContract Medical International GmbHDYB2024-08-19