Flowmeter, Digital Flexmount, 4 Cyl., SS - Flowmeter, Digital Flexmount, 4 Cyl., SS - ACCUTRON, INC.

Duns Number:088302096

Device Description: Flowmeter, Digital Flexmount, 4 Cyl., SS

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More Product Details

Catalog Number

26400-4CSS

Brand Name

Flowmeter, Digital Flexmount, 4 Cyl., SS

Version/Model Number

26400-4CSS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 31, 2199

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

-

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

K052335

Product Code Details

Product Code

BSZ

Product Code Name

Gas-Machine, Anesthesia

Device Record Status

Public Device Record Key

9422ad07-a273-45f8-90ab-7fc4562ed5d0

Public Version Date

October 01, 2018

Public Version Number

1

DI Record Publish Date

August 31, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACCUTRON, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 344
2 A medical device with a moderate to high risk that requires special controls. 192