FDA.reportPublic FDA data

Valved Introducer

Primary DI
M991IK522211
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
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
M991IK522212PackageHIBCC2In Commercial Distribution
M991IK522211PrimaryHIBCC0

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
M991IK712211Standard IntroducerStraight Wing TearawayIK712212015-09-01
M991IK722211Valved IntroducerFlowguardIK722212015-09-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-27
06974949030920CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
06974949030944CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
10884450119836Prelude EASE™Merit Medical Systems, Inc.DYB2026-08-27
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-18
00199874352930Transseptal Puncture DevicePROTARYX MEDICAL INC.DYB2026-07-15
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
10801902190519ARROWTELEFLEX INCORPORATEDDYB2021-09-02
04251244500641DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500719DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500801DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500818DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500832DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500849DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500856DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501099DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501075DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501082DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500795DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2020-11-04
00389701012353R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012360R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012377R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012384R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
04251244500108DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500115DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500122DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500139DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500146DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500153DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30