Dual Nasal Hood For Anesthesia with LuerSafe CO2 Monitoring Single Use Small Str - FLEXICARE MEDICAL LIMITED

Duns Number:504406273

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Dual Nasal Hood For Anesthesia with LuerSafe CO2 Monitoring Single Use Small Str

Version/Model Number

035-55-310SU

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

-

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

-

Product Code Details

Product Code

CCK

Product Code Name

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Device Record Status

Public Device Record Key

0fd3d9ef-c239-46fd-af08-622c1e956460

Public Version Date

March 19, 2020

Public Version Number

1

DI Record Publish Date

March 11, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FLEXICARE MEDICAL LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 715
2 A medical device with a moderate to high risk that requires special controls. 465