BaaySCI Disposable Nasal Swab - BaaySCI Disposable Nasal Swab . Specimen - HOME AIDE DIAGNOSTICS, INC.

Duns Number:783518983

Device Description: BaaySCI Disposable Nasal Swab . Specimen collection swab . Laboratory use

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More Product Details

Catalog Number

-

Brand Name

BaaySCI Disposable Nasal Swab

Version/Model Number

BaayNS

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

KXG

Product Code Name

Applicator, Absorbent Tipped, Sterile

Device Record Status

Public Device Record Key

db9ccc0a-7dfb-4949-9b13-1e45a09b7b56

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

June 11, 2021

Additional Identifiers

Package DI Number

10891237001963

Quantity per Package

250

Contains DI Package

00891237001966

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton

"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