AccessGUDID - DEVICE: Aveir™ (05415067031914)

GUDID

Device Identifier (DI) Information

Brand Name: Aveir™
Version or Model: LSL02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LSL02
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067031914
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790268031 *Terms of Use

Device Description: Link Module Programmer Communication Module

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
60887	Intracardiac pacemaker programming interface unit	An external, electronic device intended to interface a dedicated patient lead (cable with skin surface electrodes) with a pacemaker programmer (from which it draws its power), to enable noninvasive interrogation and programming of an implanted intracardiac pacemaker using high frequency electrical pulses (as an alternative to wireless communication); it is also intended to collect electrocardiogram (ECG) data for observation of pacemaker function. Pacemaker communication and ECG data collection is achieved via the patient cable/electrodes which are typically included. The device is intended to be used by a healthcare professional in a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PNJ	Leadless pacemaker

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P150035	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Temperature: between 50 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a697449f-d9ff-4647-af09-f0f59dd924a4
Public Version Date: August 14, 2023
Public Version Number: 3
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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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