Pediatric Heart Cooling Jacket - Cardiomed Supplies Inc

Duns Number:240623124

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More Product Details

Catalog Number

17-262

Brand Name

Pediatric Heart Cooling Jacket

Version/Model Number

2.0

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

K833112,K833112

Product Code Details

Product Code

DWF

Product Code Name

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

47144998-c842-469d-8d1f-403b2c79d68e

Public Version Date

April 29, 2021

Public Version Number

1

DI Record Publish Date

April 21, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARDIOMED SUPPLIES INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 34