Infant Nasal Cannula with Soft Tip Prongs and 2.1m Oxygen Tubing - FLEXICARE MEDICAL LIMITED

Duns Number:504406273

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More Product Details

Catalog Number

-

Brand Name

Infant Nasal Cannula with Soft Tip Prongs and 2.1m Oxygen Tubing

Version/Model Number

032-10-115U

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)

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

CAT

Product Code Name

Cannula, Nasal, Oxygen

Device Record Status

Public Device Record Key

72377e9a-a997-4ff5-b8fa-6d14ea7cc8b7

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

January 28, 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