Dealmed - Emesis Bag Graduated Blue, 24/Pk - DEALMED MEDICAL SUPPLIES LLC

Duns Number:068586441

Device Description: Emesis Bag Graduated Blue, 24/Pk

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More Product Details

Catalog Number

784070

Brand Name

Dealmed

Version/Model Number

784070

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)

-

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

FNY

Product Code Name

BASIN, EMESIS

Device Record Status

Public Device Record Key

1c03c475-4339-4ea0-8c90-20106852d345

Public Version Date

November 20, 2020

Public Version Number

1

DI Record Publish Date

November 12, 2020

Additional Identifiers

Package DI Number

10817415020823

Quantity per Package

6

Contains DI Package

00817415020826

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"DEALMED MEDICAL SUPPLIES LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 6