Vital Signs™ - CAPNOSTAT Adult/Pediatric Airway Adapter, - Vyaire Medical Oy

Duns Number:368457563

Device Description: CAPNOSTAT Adult/Pediatric Airway Adapter, Disposable

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More Product Details

Catalog Number

415036-001

Brand Name

Vital Signs™

Version/Model Number

415036-001

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

BZA

Product Code Name

Connector, Airway (Extension)

Device Record Status

Public Device Record Key

8d7d8f12-da39-4b1e-b24b-73321fe09b3d

Public Version Date

December 07, 2020

Public Version Number

1

DI Record Publish Date

November 27, 2020

Additional Identifiers

Package DI Number

50190752110753

Quantity per Package

20

Contains DI Package

10190752110755

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"VYAIRE MEDICAL OY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 600