Catalog Number

-

Brand Name

PerkinElmer 226

Version/Model Number

Newborn Screening Card

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K121864,K121864

Product Code

PJC

Product Code Name

Newborn Screening Specimen Collection Paper

Public Device Record Key

be756e89-814c-4356-83a3-bfb7d719183c

Public Version Date

September 23, 2022

Public Version Number

4

DI Record Publish Date

August 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-