HUMIDIFIER HOLDER - Sales kit containing:1 pc Humidification holder - Maquet Critical Care AB

Duns Number:632707092

Device Description: Sales kit containing:1 pc Humidification holder assembly 073257100042581 pc Rail clamp 073 Sales kit containing:1 pc Humidification holder assembly 073257100042581 pc Rail clamp 07325710004265

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More Product Details

Catalog Number

-

Brand Name

HUMIDIFIER HOLDER

Version/Model Number

6693735

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

K151814,K180098,K201874

Product Code Details

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Device Record Status

Public Device Record Key

cfed6df7-0693-4689-9320-7ff76eb9915f

Public Version Date

June 09, 2021

Public Version Number

5

DI Record Publish Date

February 09, 2016

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