Statcorp Medical - BP CUFF,TL SOFT,1T,SMALLADULT,18-26CM,5/BG - Statcorp Medical

Duns Number:602075905

Device Description: BP CUFF,TL SOFT,1T,SMALLADULT,18-26CM,5/BG

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More Product Details

Catalog Number

715-1133-10

Brand Name

Statcorp Medical

Version/Model Number

STATCORP

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"

Yes

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

K940214

Product Code Details

Product Code

DXQ

Product Code Name

blood pressure cuff

Device Record Status

Public Device Record Key

050969f2-d20d-4fbc-a50b-80db7817cd8c

Public Version Date

June 09, 2021

Public Version Number

6

DI Record Publish Date

November 28, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STATCORP MEDICAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 98
2 A medical device with a moderate to high risk that requires special controls. 528