Catalog Number

370344G

Brand Name

Bloom2

Version/Model Number

Bloom2 Console

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K173439

Product Code

JOQ

Product Code Name

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

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

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-