NA - E-SCAIOVX-00, MODULE ASSEMBLY - GE Healthcare Finland Oy

Duns Number:401966697

Device Description: E-SCAIOVX-00, MODULE ASSEMBLY

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

E-sCAiOVX-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

BZK

Product Code Name

Spirometer, monitoring (w/wo alarm)

Device Record Status

Public Device Record Key

d5a2530e-369d-4814-9115-5d5742add0c4

Public Version Date

February 24, 2022

Public Version Number

7

DI Record Publish Date

June 03, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GE HEALTHCARE FINLAND OY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 224