Aeroneb Module, SERVO-i - Following Device Identifier number is included in - Maquet Critical Care AB

Duns Number:632707092

Device Description: Following Device Identifier number is included in this KIT:07325710004807,07325710002841

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More Product Details

Catalog Number

-

Brand Name

Aeroneb Module, SERVO-i

Version/Model Number

6685342

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

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Device Record Status

Public Device Record Key

fbc795e7-a63e-4e7d-951d-41a07584e256

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 23, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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