PEMCO INC - Perfusion Cannula. Tube Handle 9.5 inches long. - PEMCO INC

Duns Number:004217071

Device Description: Perfusion Cannula. Tube Handle 9.5 inches long. Style # 8 Fixed Tip - 3 MM Tip Diameter. Perfusion Cannula. Tube Handle 9.5 inches long. Style # 8 Fixed Tip - 3 MM Tip Diameter. 90 Degree Bend.Also available in: Large, Flag, & Small, Handle Styles

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More Product Details

Catalog Number

1580-T-08-3MM-90

Brand Name

PEMCO INC

Version/Model Number

1580-T-08-3MM-90

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

DWF

Product Code Name

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

0ca24c30-fc25-4dac-97cf-5061cb1d1077

Public Version Date

February 21, 2019

Public Version Number

3

DI Record Publish Date

September 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PEMCO INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 58
2 A medical device with a moderate to high risk that requires special controls. 160