Anesthesia Kit - Anesthesia Kit - The Children's Hospital Boston, - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: Anesthesia Kit - The Children's Hospital Boston, MA

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More Product Details

Catalog Number

049974701B

Brand Name

Anesthesia Kit

Version/Model Number

049974701B

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

DRS

Product Code Name

Transducer, Blood-Pressure, Extravascular

Device Record Status

Public Device Record Key

1ec1a556-8405-4b62-ab29-cd7350df17ba

Public Version Date

January 23, 2019

Public Version Number

3

DI Record Publish Date

September 12, 2016

Additional Identifiers

Package DI Number

20886333203127

Quantity per Package

20

Contains DI Package

00886333203123

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ARGON MEDICAL DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 347
2 A medical device with a moderate to high risk that requires special controls. 1205