Dual Pediatric Nasal Cannula 14ft O2 Delivery/CO2 Monitoring, Filter, Microstrea - Dual Pediatric Nasal Cannula 14ft O2 Delivery/CO2 - FLEXICARE MEDICAL LIMITED

Duns Number:504406273

Device Description: Dual Pediatric Nasal Cannula 14ft O2 Delivery/CO2 Monitoring, Filter, Microstream Luer, M- Dual Pediatric Nasal Cannula 14ft O2 Delivery/CO2 Monitoring, Filter, Microstream Luer, M-M

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More Product Details

Catalog Number

-

Brand Name

Dual Pediatric Nasal Cannula 14ft O2 Delivery/CO2 Monitoring, Filter, Microstrea

Version/Model Number

032-12-183/1U

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

K140113

Product Code Details

Product Code

CAT

Product Code Name

Cannula, Nasal, Oxygen

Device Record Status

Public Device Record Key

2b09317d-58ba-4369-aef6-331c4d985b31

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

March 27, 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