Emergency Medical Products - Complete Latex-free 1st Call-in Bag - EMERGENCY MEDICAL PRODUCTS, INC.

Duns Number:061738290

Device Description: Complete Latex-free 1st Call-in Bag

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More Product Details

Catalog Number

-

Brand Name

Emergency Medical Products

Version/Model Number

FCBLF-NVY

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

Yes

Prescription Use (Rx)

Yes

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

CAN

Product Code Name

REGULATOR, PRESSURE, GAS CYLINDER

Device Record Status

Public Device Record Key

6a5b74fe-daf5-4a8a-af9c-a096ca681f60

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EMERGENCY MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 2