Spacelabs Healthcare - DATUM+ABBVIE 5% ISO SELECTATEC STANDARD FILL - SPACELABS HEALTHCARE (WASHINGTON), INC

Duns Number:145581588

Device Description: DATUM+ABBVIE 5% ISO SELECTATEC STANDARD FILL

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More Product Details

Catalog Number

13012261

Brand Name

Spacelabs Healthcare

Version/Model Number

DATUM

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 12, 2019

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

K942799

Product Code Details

Product Code

CAD

Product Code Name

VAPORIZER, ANESTHESIA, NON-HEATED

Device Record Status

Public Device Record Key

75dae1ab-cbd8-4d60-b63d-813c28576137

Public Version Date

July 12, 2019

Public Version Number

5

DI Record Publish Date

January 03, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPACELABS HEALTHCARE (WASHINGTON), INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 732