Catalog Number

EVAC1000

Brand Name

One-Vac™

Version/Model Number

00884450534113

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

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

-

Product Code

KDQ

Product Code Name

BOTTLE, COLLECTION, VACUUM

Public Device Record Key

f5cd84bd-0804-42d1-8e00-2b07959133f6

Public Version Date

July 27, 2021

Public Version Number

1

DI Record Publish Date

July 19, 2021

Package DI Number

10884450534110

Quantity per Package

10

Contains DI Package

00884450534113

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-