DAR - Electrostatic Spirometry Filter Adapter - Covidien LP

Duns Number:058614483

Device Description: Electrostatic Spirometry Filter Adapter

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More Product Details

Catalog Number

-

Brand Name

DAR

Version/Model Number

R013

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

CAH

Product Code Name

Filter, bacterial, breathing-circuit

Device Record Status

Public Device Record Key

50683cfc-6866-46b5-8872-7a83d79aef0c

Public Version Date

January 11, 2022

Public Version Number

7

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10884522032117

Quantity per Package

10

Contains DI Package

20884522032114

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"COVIDIEN LP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 132
2 A medical device with a moderate to high risk that requires special controls. 8540
3 A medical device with high risk that requires premarket approval 202
U Unclassified 40