AccessGUDID - DEVICE: AVEIR™ (05415067046468)

GUDID

Device Identifier (DI) Information

Brand Name: AVEIR™
Version or Model: LSRMC01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LSRMC01
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067046468
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790268031 *Terms of Use

Device Description: Patient Transmitter Wired Electrodes

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:	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?
47269	Transtelephonic implantable pacemaker analysis system	An assembly of devices designed to analyse the performance of an implanted pacemaker based on electrocardiographic measurements that can be monitored transtelephonically. It typically includes a computer-based pacemaker analyser, a 12-lead electrocardiograph (ECG), and a transtelephonic receiver and/or transmitter. It provides data taken directly from the patient (e.g., ECG electrodes are applied to the patient and a test magnet is placed over the pacemaker to activate it) or a pacemaker programmer. Signals are sent to the receiver where pacemaker function information is displayed. This system may also include a database that collects and stores patient data.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PNJ	Leadless pacemaker

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P150035	007

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
Storage Environment Temperature: between -13 and 140 Degrees Fahrenheit
Special Storage Condition, Specify: Keep dry. Keep away from sunlight. Protect from heat and radioactive sources
Handling Environment Temperature: between -13 and 140 Degrees Fahrenheit
Storage Environment Temperature: between -25 and 60 Degrees Celsius
Handling Environment Temperature: between -25 and 60 Degrees Celsius
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 0 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 793ce3f8-6066-4a7b-9141-22a88ad01eb1
Public Version Date: December 19, 2024
Public Version Number: 1
DI Record Publish Date: December 11, 2024

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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