Hopkins Medical Products® - Hopkins Large Adult Latex Free Nylon Sphyg - HOPKINS UNIFORM COMPANY

Duns Number:003080678

Device Description: Hopkins Large Adult Latex Free Nylon Sphyg

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More Product Details

Catalog Number

526646

Brand Name

Hopkins Medical Products®

Version/Model Number

526646

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

DXN

Product Code Name

SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Device Record Status

Public Device Record Key

e1db7692-d839-4290-a21c-337dc6c3cf4a

Public Version Date

October 29, 2018

Public Version Number

1

DI Record Publish Date

September 28, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HOPKINS UNIFORM COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 96
2 A medical device with a moderate to high risk that requires special controls. 135