Start-Up Kit Extended Length - 9 foot tubing set including integral air trap - Zoll Circulation, Inc.

Duns Number:799455241

Device Description: 9 foot tubing set including integral air trap chamber and stainless steel heat exchange co

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More Product Details

Catalog Number

8700-0667-01

Brand Name

Start-Up Kit Extended Length

Version/Model Number

CG-500D EX

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

K014241

Product Code Details

Product Code

NCX

Product Code Name

System, Hypothermia, Intravenous, Cooling

Device Record Status

Public Device Record Key

c28bfc3a-6524-4e2a-a78c-f3c84124f9ea

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 31, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZOLL CIRCULATION, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 331
3 A medical device with high risk that requires premarket approval 1