AccessGUDID - DEVICE: Aveir™ (05415067034496)

GUDID

Device Identifier (DI) Information

Brand Name: Aveir™
Version or Model: LSCR111
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LSCR111
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067034496
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790268031 *Terms of Use

Device Description: Retrieval Catheter

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
60881	Intracardiac pacemaker extraction catheter	A sterile, steerable flexible tube with a distal snaring mechanism intended to be introduced into the right ventricle of the heart, via transcutaneous peripheral venous access (e.g., femoral vein), to remove an implanted intracardiac pacemaker; it may also be used to remove an intracardiac pacemaker that has migrated to the peripheral vasculature. It typically has control handle with flush ports, and a single- or multi-looped snare which emerges from the distal tip of the catheter; it may include devices dedicated to catheter introduction (e.g., introducer, guidewire). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMX	Device, percutaneous retrieval

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K213494	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. Keep away from sunlight.

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 6.8000 Millimeter
Length: 105.0000 Centimeter

Device Record Status

Public Device Record Key: 8032bef1-9fa8-4328-adbf-0a2d24e10028
Public Version Date: October 02, 2023
Public Version Number: 2
DI Record Publish Date: March 03, 2023

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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(855)478-5833
Email: customerservice@sjm.com

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