ZevRx Alcohol Pads 100cnt - • 2-ply pads• Saturated with 70% isopropyl - HOME AIDE DIAGNOSTICS, INC.

Duns Number:783518983

Device Description: • 2-ply pads• Saturated with 70% isopropyl alcohol• 100 individually packed alcohol pad • 2-ply pads• Saturated with 70% isopropyl alcohol• 100 individually packed alcohol pads per box• For external use only

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More Product Details

Catalog Number

-

Brand Name

ZevRx Alcohol Pads 100cnt

Version/Model Number

1

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

LKB

Product Code Name

Pad, Alcohol, Device Disinfectant

Device Record Status

Public Device Record Key

2fffaf4f-11ef-4ea9-9bce-1c1ec42eb329

Public Version Date

August 24, 2022

Public Version Number

1

DI Record Publish Date

August 16, 2022

Additional Identifiers

Package DI Number

10850632007758

Quantity per Package

100

Contains DI Package

00850632007751

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"HOME AIDE DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 44
U Unclassified 11