AccessGUDID - DEVICE: Bloom2 (00863019000368)

GUDID

Device Identifier (DI) Information

Brand Name: Bloom2
Version or Model: Bloom2 Console
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 370344G
Company Name: Fischer Medical

Primary DI Number: 00863019000368
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079978232 *Terms of Use

Device Description: Bloom2 Cardiac Stimulator System: External Programmable Pacemaker Pulse 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?
35974	Cardiac electrophysiology stimulation system	An assembly of devices programmed to deliver precisely timed electrical impulses to the heart, during spontaneous and paced rhythms, for diagnostic cardiac stimulation. It typically includes electrodes/leads applied to the heart and an external pulse generator (EPG). It may be used in asynchronous or synchronous mode, to deliver stimuli of variable strength, and for pacing in a wide range of cycle lengths (typically from 150 to 1500 ms). It is used for performing physiologic cardiac tests such as to determine the function of various components of the atrioventricular conduction, factors required for induction and termination of tachycardia, and to assess sinus node function.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOQ	Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173439	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 99798d7e-2be4-4560-982c-e5ec62ec22e9
Public Version Date: March 03, 2021
Public Version Number: 1
DI Record Publish Date: February 23, 2021