NA - D-LITE++ PATIENT SPIROMETRY SET, 2M/7FT, 1 PCS - GE Healthcare Finland Oy

Duns Number:401966697

Device Description: D-LITE++ PATIENT SPIROMETRY SET, 2M/7FT, 1 PCS

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

D-LITE PATIENT SPIROMETRY SET 2104297-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K211171,K183394,K211171,K183394

Product Code Details

Product Code

BZK

Product Code Name

Spirometer, monitoring (w/wo alarm)

Device Record Status

Public Device Record Key

87eade2c-0071-4c3f-8fe9-99fdbd9dae4f

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

June 19, 2019

Additional Identifiers

Package DI Number

00840682138246

Quantity per Package

20

Contains DI Package

00840682138161

Package Discontinue Date

-

Package Status

In Commercial Distribution

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