IMCO - Standard Bulb and Valve - INDEPENDENT MEDICAL CO-OP, INC.

Duns Number:073436164

Device Description: Standard Bulb and Valve

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More Product Details

Catalog Number

-

Brand Name

IMCO

Version/Model Number

875-IMC

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Device Record Status

Public Device Record Key

7158ab87-361c-42d1-9732-35c787e627cf

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 10, 2016

Additional Identifiers

Package DI Number

10815842023103

Quantity per Package

100

Contains DI Package

00815842023106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"INDEPENDENT MEDICAL CO-OP, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 42