NBP Cuff XS, 12-19cm - Drägerwerk AG & Co. KGaA

Duns Number:315578914

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More Product Details

Catalog Number

-

Brand Name

NBP Cuff XS, 12-19cm

Version/Model Number

MP00912

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

K092999

Product Code Details

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Device Record Status

Public Device Record Key

05fc0cf0-b3a7-43ee-bc7b-7e0f01161065

Public Version Date

July 22, 2019

Public Version Number

4

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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