AccessGUDID - DEVICE: Ampere™ (05415067046734)

GUDID

Device Identifier (DI) Information

Brand Name: Ampere™
Version or Model: H700488-CQM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H700488-CQM
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067046734
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use

Device Description: Generator

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?
60784	Cardiac radio-frequency ablation system generator	An electrically-powered, noninvasive device intended to be used to generate radio-frequency energy to create ablative lesions in the cardiac tissue of a beating heart in the treatment of cardiac arrhythmias. The generator includes controls and may include electrocardiograph (ECG) interfacing/monitoring functionality. It may be intended to be used with a radio-frequency catheter for endocardial ablation and/or an epicardial probe for epicardial ablation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAE	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
OAD	catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
LPB	Cardiac ablation percutaneous catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 -20 and 60 Degrees Celsius
Special Storage Condition, Specify: Keep dry.
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 71dbb113-a224-4511-8b51-5bcae4bc5e3d
Public Version Date: January 22, 2025
Public Version Number: 1
DI Record Publish Date: January 14, 2025

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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