Gas sampling line 2.0m (M/M) - Maquet Critical Care AB

Duns Number:632707092

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More Product Details

Catalog Number

-

Brand Name

Gas sampling line 2.0m (M/M)

Version/Model Number

6693510

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

K133958,K133958

Product Code Details

Product Code

BSZ

Product Code Name

Gas-Machine, Anesthesia

Device Record Status

Public Device Record Key

8db326e7-d62c-4b47-bb12-e70b5fd82386

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 30, 2015

Additional Identifiers

Package DI Number

17325710002510

Quantity per Package

25

Contains DI Package

07325710002513

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