etCO2 Airway adapter Neonatal disp. 1pcs - Maquet Critical Care AB

Duns Number:632707092

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More Product Details

Catalog Number

-

Brand Name

etCO2 Airway adapter Neonatal disp. 1pcs

Version/Model Number

6884536

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

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Device Record Status

Public Device Record Key

63b5c6a6-d733-4059-b12a-0b435f866787

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 23, 2015

Additional Identifiers

Package DI Number

17325710004231

Quantity per Package

10

Contains DI Package

07325710004234

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MAQUET CRITICAL CARE AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 62
2 A medical device with a moderate to high risk that requires special controls. 131