AccessGUDID - DEVICE: wtATTR-CM AcceleraTTR™ (05415062388310)

GUDID

Device Identifier (DI) Information

Brand Name: wtATTR-CM AcceleraTTR™
Version or Model: CI4054279
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PFIZER INC.

Primary DI Number: 05415062388310
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 829076566 *Terms of Use

Device Description: Software to identify heart failure patients who may be at risk of having wtATTR-CM

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):	No
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?
64918	Cardiovascular interpretive screening software	An interpretive software program intended to be used in the assessment of risk/probability for having a cardiovascular condition (e.g., significant coronary stenosis) or event (e.g., heart attack, ischemic stroke, unstable angina, coronary revascularization). It typically combines some of the following data: patient demographics, physical measurements, symptoms, medical history, results of the qualitative/quantitative clinical specimen in vitro diagnostic (IVD) tests. It typically creates a risk score or probability that may be used to guide patient management. It is not intended to produce risk scores for renal disease; this software is not an IVD device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JQP	Calculator/data processing module, for clinical use

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 368e1cba-f4da-46fe-baa7-eb72c69e3d42
Public Version Date: August 07, 2024
Public Version Number: 2
DI Record Publish Date: July 29, 2022