HAMILTON-C3 - Hamilton Medical AG

Duns Number:481492312

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More Product Details

Catalog Number

160005

Brand Name

HAMILTON-C3

Version/Model Number

160005

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

dc7b385a-df3a-4d62-8db9-21b70b73e85d

Public Version Date

January 27, 2022

Public Version Number

3

DI Record Publish Date

October 21, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HAMILTON MEDICAL AG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 19