FDA.reportPublic FDA data

Peel-Apart Percutaneous Introducer Kit

Primary DI
00801741038280
Brand
Peel-Apart Percutaneous Introducer Kit
Company
Bard Access Systems, Inc.
Model
0601114
Catalog number
0601114
Device description
14 Fr. PTFE Peel-Apart Percutaneous Introducer Kit
Published
2016-02-22
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

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
10801741038287PackageGS112In Commercial Distribution
00801741038280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174103828710801741038287
00801741038280008017410382808017410382800801741038280

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/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0

Contacts#

Phone, Email table
PhoneEmail
+1(800)545-0890medical.services@crbard.com

Regulatory Flags#

DUNS number
044611812
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741038204MicroEZ Introducer012894501289452016-02-08
00801741038211MicroEZ Introducer012895001289502016-02-08
00801741038228MicroEZ Introducer012896001289602016-02-08
00801741038235MicroEZ Introducer022894502289452016-02-08
00801741038242MicroEZ Introducer022895002289502016-02-08
00801741038259MicroEZ Introducer022896002289602016-02-08
00801741038266Peel-Apart Percutaneous Introducer Kit060111006011102016-02-22
00801741038273Peel-Apart Percutaneous Introducer Kit060111306011132016-02-22
00801741038297Peel-Apart Percutaneous Introducer Kit060111506011152016-02-22
00801741038303Peel-Apart Percutaneous Introducer Kit060115006011502016-02-22
00801741038310Peel-Apart Percutaneous Introducer Kit060116506011652016-02-22
00801741038327Peel-Apart Percutaneous Introducer Kit060117006011702016-02-22
00801741038334Peel-Apart Percutaneous Introducer Kit060771006077102016-02-22
00801741038341Peel-Apart Percutaneous Introducer Kit060777006077702016-02-22
00801741038358Peel-Apart Percutaneous Introducer Kit060778006077802016-02-22
00801741038365MicroEZ Introducer067893506789352016-02-08
00801741038372MicroEZ Introducer067894506789452016-02-08
00801741038389MicroEZ Introducer067895006789502016-02-08
00801741038396MicroEZ Introducer067896006789602016-02-08
00801741038402MicroEZ Introducer068893506889352016-02-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00389701011912GLIDESHEATH SLENDER TIBIAL PEDAL KITTERUMO MEDICAL CORPORATIONDYB2018-08-31
00389701011950GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701011967GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701011974GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701011981GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701009261PINNACLETERUMO MEDICAL CORPORATIONDYB2018-03-21
00382903840120BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840083BD Introsyte-N Autoguard, BD InstaflashBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840106BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840113BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00389701006161DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006178DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006185DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006192DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006208DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006215DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006222DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006239DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006246DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006253DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006260DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006277DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006796DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006802DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006970DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006987DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006994DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701007007DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701007168DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24