VPC NRFit 10ml - VPC NRFit 10ml sterile - Pajunk GmbH Medizintechnologie

Duns Number:317654283

Device Description: VPC NRFit 10ml sterile

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More Product Details

Catalog Number

0001163-49

Brand Name

VPC NRFit 10ml

Version/Model Number

0001163-49

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

March 15, 2025

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K190345,K190345

Product Code Details

Product Code

CAZ

Product Code Name

Anesthesia conduction kit

Device Record Status

Public Device Record Key

c5717fce-0a9b-4791-b4d3-c3f87247ab35

Public Version Date

February 23, 2021

Public Version Number

3

DI Record Publish Date

July 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PAJUNK GMBH MEDIZINTECHNOLOGIE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 35
2 A medical device with a moderate to high risk that requires special controls. 979