T-adapter MX300/MX300i 15mm, disposable - Drägerwerk AG & Co. KGaA

Duns Number:315578914

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More Product Details

Catalog Number

-

Brand Name

T-adapter MX300/MX300i 15mm, disposable

Version/Model Number

MP01880

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)

-

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

BZO

Product Code Name

Set, Tubing And Support, Ventilator (W Harness)

Device Record Status

Public Device Record Key

556e1acf-36c1-4ed9-8d49-53f9b52b1691

Public Version Date

October 21, 2020

Public Version Number

5

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

04048675398233

Quantity per Package

20

Contains DI Package

04048675420682

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"DRÄGERWERK AG & CO. KGAA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 220
2 A medical device with a moderate to high risk that requires special controls. 160