Tech-Med - Standard Sphyg., Nylon Black, Lg. Adult Latex - Dukal LLC

Duns Number:791014871

Device Description: Standard Sphyg., Nylon Black, Lg. Adult Latex Free

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More Product Details

Catalog Number

2024x

Brand Name

Tech-Med

Version/Model Number

2024x

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K193259,K193259

Product Code Details

Product Code

DXQ

Product Code Name

blood pressure cuff

Device Record Status

Public Device Record Key

b70f900e-0e81-4461-a738-334ad752d804

Public Version Date

May 23, 2022

Public Version Number

9

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20665973017031

Quantity per Package

40

Contains DI Package

00665973017037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"DUKAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 31
U Unclassified 1