FERNO2 - Silicone Cuffed Mask: Size 0 - Spiracle Technology

Duns Number:836002451

Device Description: Silicone Cuffed Mask: Size 0

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More Product Details

Catalog Number

-

Brand Name

FERNO2

Version/Model Number

T50550-00

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)

-

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

KGB

Product Code Name

Mask, Oxygen, Non-Rebreathing

Device Record Status

Public Device Record Key

2a5d62cb-d6d2-446b-82d3-cff547a5f36e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 12, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPIRACLE TECHNOLOGY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 10