Care One - FPPL Care One DPS +/- - Ahold U.S.A., Inc.

Duns Number:170199058

Device Description: FPPL Care One DPS +/-

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More Product Details

Catalog Number

-

Brand Name

Care One

Version/Model Number

One Step Pregnancy Test

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

K042280,K042280,K042280

Product Code Details

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Device Record Status

Public Device Record Key

f1c45999-0e43-48c9-8cb7-3f52a102afea

Public Version Date

April 30, 2021

Public Version Number

1

DI Record Publish Date

April 22, 2021

Additional Identifiers

Package DI Number

10041520171273

Quantity per Package

24

Contains DI Package

00041520171276

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipper

"AHOLD U.S.A., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 28
2 A medical device with a moderate to high risk that requires special controls. 12
U Unclassified 2