Greater Goods - Balance Aneroid Sphygmomanometer (Free Basic - Greater Goods

Duns Number:189583599

Device Description: Balance Aneroid Sphygmomanometer (Free Basic Stethoscope or $10 voucher for Stethoscope)

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More Product Details

Catalog Number

-

Brand Name

Greater Goods

Version/Model Number

0610

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

K090014,K090014

Product Code Details

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Device Record Status

Public Device Record Key

e1632b5f-bce8-4f35-8eb8-ec0a3abf617e

Public Version Date

November 11, 2020

Public Version Number

1

DI Record Publish Date

November 03, 2020

Additional Identifiers

Package DI Number

10875011006108

Quantity per Package

25

Contains DI Package

00875011006101

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"GREATER GOODS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12
2 A medical device with a moderate to high risk that requires special controls. 30