Jet-Vac - Jet-Vac 1500D - PFM MEDICAL INCORPORATED

Duns Number:097736867

Device Description: Jet-Vac 1500D

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More Product Details

Catalog Number

M7095

Brand Name

Jet-Vac

Version/Model Number

M7095

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)

Yes

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

KDQ

Product Code Name

Bottle, Collection, Vacuum

Device Record Status

Public Device Record Key

1d4ee08c-2148-473e-85ee-8b9a532f36aa

Public Version Date

September 06, 2019

Public Version Number

3

DI Record Publish Date

October 02, 2016

Additional Identifiers

Package DI Number

10813623012971

Quantity per Package

10

Contains DI Package

00813623012974

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"PFM MEDICAL INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 109