AccessGUDID - DEVICE: Abre™ (00643169796478)

GUDID

Device Identifier (DI) Information

Brand Name: Abre™
Version or Model: AB9U20150090
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00643169796478
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: STENT AB9U20150090 ABRE V01

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58057	Bare-metal peripheral venous stent	A non-bioabsorbable, tubular device made of metal intended to be implanted in a peripheral (typically the iliac and/or femoral) vein to maintain patency in patients with constrained venous outflow; it is not intended for coronary or intracranial venous stenting. It is inserted and advanced to the site of implantation with a dedicated catheter where it self-expands upon release. It 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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QAN	Stent, iliac vein

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P200026	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Stent Diameter 20 X 150 MM
Device Size Text, specify: Lumen Diameter 17.5 - 19 MM
Stent Length: 150.0 Millimeter
Device Size Text, specify: Minimum Sheath 9FR
Device Size Text, specify: Working Length 90 CM

Device Record Status

Public Device Record Key: 2fbe3c7f-5369-43f9-962a-32d960b7fbce
Public Version Date: November 25, 2024
Public Version Number: 3
DI Record Publish Date: November 01, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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