Abre™

Primary DI
00643169796430
Brand
Abre™
Company
MEDTRONIC, INC.
Model
AB9U20060090
Device description
STENT AB9U20060090 ABRE V01
Published
2020-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QANStent, iliac vein

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QANStent, Iliac VeinUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P200026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200026000Abre Venous Self-expanding Stent SystemMedtronic Vascular, Inc.2020-10-21QAN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169796430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169796430006431697964306431697964300643169796430

GMDN Terms#

Term, Definition table
TermDefinition
Iliofemoral vein stentA sterile non-bioabsorbable tubular device intended to be implanted in an iliac and/or femoral vein to maintain patency in patients with constrained venous outflow. It is inserted and advanced to the site of implantation with a dedicated catheter where it self-expands upon release. The device is typically made of nickel-titanium alloy (Nitinol) and has radiopaque marker(s) for visualization; it is available in a variety of diameters and lengths. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Stent Length60Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810010693266Duo Extend Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010693280Duo Extend Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010693327Duo Extend Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010693341Duo Extend Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010693440Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010693457Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010693464Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010693471Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010694782Duo Extend Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010694829Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010694836Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010694843Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010694850Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010694898Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
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