AccessGUDID - DEVICE: Quadra Allure MP™ (05414734510097)

GUDID

Device Identifier (DI) Information

Brand Name: Quadra Allure MP™
Version or Model: PM3562
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PM3562
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05414734510097
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790268031 *Terms of Use

Device Description: CRT Cardiac Resynchronization Therapy Pacemaker DDDRV

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?
47263	Cardiac resynchronization therapy implantable pacemaker	A battery-powered, hermetically-sealed pulse generator, intended to be implanted beneath the skin of the chest in a surgically-created pocket, and used with pacing leads placed in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber) to stimulate the heart to beat at a faster rate when it senses bradycardia and provides cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions to treat symptoms of heart failure (e.g., easy fatigue) and serious heart-rhythm problems [CRT pacemaker (CRT-P)]; it is not intended for defibrillation therapy.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NKE	Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P030035	171
P030035	175
P030035	177

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bf070be6-269c-4b40-9e55-b489f58dcb51
Public Version Date: October 02, 2024
Public Version Number: 4
DI Record Publish Date: January 15, 2019

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

Customer Contact

[?]

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

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES